Encore Medical, LP recall records

41 reported ongoing

43 records in this archive. Latest source date Feb 16, 2026.

FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

Records and reported status

FDA device enforcement

Brand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 11L 14MM, VE Model/Catalog Number: 342-19-703 Product Description: Enovis knee devices are intended for knee arthrop...

Due to packaging discrepancy with incorrect product size mixed up.

Class IIReported ongoing

Distribution: GL112 Certus Medical LLC Indiana (IN) & Michigan (MI) 342-19-703 177T1057 EMPOWR 3D KNEETM INS, 3R 19MM, VE 1 MW001 Fox Medtech, LLC Colorado (CO), Wyoming (WY), Montana (MT), C...

Official source for Brand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 11L 14MM, VE Model/Catalog Number: 3...
FDA device enforcement

Brand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 11L 14MM, VE Model/Catalog Number: 341-14-711 Product Description: Enovis knee devices are for knee arthroplasty.

Due to packaging discrepancy with incorrect product size mixed up.

Class IIReported ongoing

Distribution: GL112 Certus Medical LLC Indiana (IN) & Michigan (MI) 342-19-703 177T1057 EMPOWR 3D KNEETM INS, 3R 19MM, VE 1 MW001 Fox Medtech, LLC Colorado (CO), Wyoming (WY), Montana (MT), C...

Official source for Brand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 11L 14MM, VE Model/Catalog Number: 3...
FDA device enforcement

Brand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP HUMERAL SOCKET INSERT, 32MM +4MM, STANDARD HXe-plus Model/Catalog Number: 509-00-432

Knee and Humeral socket implants contain incorrect labeling.

Class IIReported ongoing

Distribution: US Nationwide distribution in the states of VA, TN, IL, IN, MI, CO, WY, MT, RI, MA, NJ, PA, MO, OK, LA, FL, CA.

Official source for Brand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP HUMERAL SOCKET INSERT, 32MM +4MM,...
FDA device enforcement

Brand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP STANDARD HUMERAL SOCKET INSERT, 36MM, HXe-plus Model/Catalog Number: 509-00-036

Knee and Humeral socket implants contain incorrect labeling.

Class IIReported ongoing

Distribution: US Nationwide distribution in the states of VA, TN, IL, IN, MI, CO, WY, MT, RI, MA, NJ, PA, MO, OK, LA, FL, CA.

Official source for Brand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP STANDARD HUMERAL SOCKET INSERT, 3...
FDA device enforcement

EMPOWR 3D Knee Tibial Insert 5R 14MM, VE, REF: 342-14-705

942-01-40G acetabular system package was found to contain 942-01-36H acetabular system; and several other acetabular system and knee insert devices may also have a packaging discrepancy, which may cause surgical delay to exchange devices or revision surgery.

Class IIReported ongoing

Distribution: US: TX, IA, MI, MS, MA, RI, NJ, PA, NY, MO, OK, PR, AL, CA

Official source for EMPOWR 3D Knee Tibial Insert 5R 14MM, VE, REF: 342-14-705
FDA device enforcement

EMPOWR Acetabular System: Liner, 10 degree Hooded, HXe+, 36H, REF: 942-01-36H; Liner, 10 degree Hooded, HXe+, 36J, REF: 942-01-36J; Liner, 10 degree Hooded, HXe+, 40G, REF: 942-...

942-01-40G acetabular system package was found to contain 942-01-36H acetabular system; and several other acetabular system and knee insert devices may also have a packaging discrepancy, which may cause surgical delay to exchange devices or revision surgery.

Class IIReported ongoing

Distribution: US: TX, IA, MI, MS, MA, RI, NJ, PA, NY, MO, OK, PR, AL, CA

Official source for EMPOWR Acetabular System: Liner, 10 degree Hooded, HXe+, 36H, REF: 942-01-36H; Liner, 10 degree H...
FDA device enforcement

Brand Name: DJO SURGICAL Product Name: ALTIVATE REVERSE WEDGE GLENOID REAMER HEAD Model/Catalog Number: 804-06-311 Product Description: Material: S.S/Nitronic, Non-Sterile

Their is a potential that the reamer may kick or bind up during or immediately prior to use.

Class IIReported ongoing

Distribution: US Nationwide distribution in the states of AL, AZ, CA, CO, FL, HI, IA, IL, IN, KS, KY, LA, MD, ME, NE, NJ, NY, OH, PR, RI, SC, TN, TX, UT, VA, WA, WI.

Official source for Brand Name: DJO SURGICAL Product Name: ALTIVATE REVERSE WEDGE GLENOID REAMER HEAD Model/Catalog N...
FDA device enforcement

Brand Name: DJO SURGICAL Product Name: ALTIVATE REVERSE WEDGE GLENOID REAMER BOSS DRILL, 6.5mm Model/Catalog Number: 804-06-312 Product Description: Material: S.S., Non Sterile

Their is a potential that the reamer may kick or bind up during or immediately prior to use.

Class IIReported ongoing

Distribution: US Nationwide distribution in the states of AL, AZ, CA, CO, FL, HI, IA, IL, IN, KS, KY, LA, MD, ME, NE, NJ, NY, OH, PR, RI, SC, TN, TX, UT, VA, WA, WI.

Official source for Brand Name: DJO SURGICAL Product Name: ALTIVATE REVERSE WEDGE GLENOID REAMER BOSS DRILL, 6.5mm Mo...
FDA device enforcement

Brand Name: DJO SURGICAL Product Name: ALTIVATE REVERSE WEDGE GLENOID REAMER SLEEVE Model/Catalog Number: 804-06-310 Product Description: Material: S.S/CoCrMo, Non-Sterile

Their is a potential that the reamer may kick or bind up during or immediately prior to use.

Class IIReported ongoing

Distribution: US Nationwide distribution in the states of AL, AZ, CA, CO, FL, HI, IA, IL, IN, KS, KY, LA, MD, ME, NE, NJ, NY, OH, PR, RI, SC, TN, TX, UT, VA, WA, WI.

Official source for Brand Name: DJO SURGICAL Product Name: ALTIVATE REVERSE WEDGE GLENOID REAMER SLEEVE Model/Catalog...
FDA device enforcement

Brand Name: DJO SURGICAL Product Name: FA S Altivate Reverse Glenoid Tray Model/Catalog Number: None Software Version: NA Product Description: Enovis" shoulder devices are inten...

Their is a potential that the reamer may kick or bind up during or immediately prior to use.

Class IIReported ongoing

Distribution: US Nationwide distribution in the states of AL, AZ, CA, CO, FL, HI, IA, IL, IN, KS, KY, LA, MD, ME, NE, NJ, NY, OH, PR, RI, SC, TN, TX, UT, VA, WA, WI.

Official source for Brand Name: DJO SURGICAL Product Name: FA S Altivate Reverse Glenoid Tray Model/Catalog Number: N...
FDA device enforcement

Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEE INS, 4L 16MM, VE Model/Catalog Number: 341-16-704 Product Description: Enovis knee devices are int...

Knee implants contain incorrect labeling (size and/or side incorrect)

Class IIReported ongoing

Distribution: US Nationwide distribution in the states of AL, AZ, CA, CO, FL, IA, IL, IN, KS, LA, NY, TN, TX.

Official source for Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEE INS, 4L 16MM, VE M...
FDA device enforcement

Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEE INS, 7R 16MM, VE Model/Catalog Number: 342-16-707 Product Description: Enovis knee devices are int...

Knee implants contain incorrect labeling (size and/or side incorrect)

Class IIReported ongoing

Distribution: US Nationwide distribution in the states of AL, AZ, CA, CO, FL, IA, IL, IN, KS, LA, NY, TN, TX.

Official source for Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEE INS, 7R 16MM, VE M...
FDA device enforcement

Brand Name: EMPOWR Dual Mobility" Product Name: EMPOWR Acetabular, Dual Mobility, Poly Bearing, ID28, OD40 Model/Catalog Number: 952-28-40E Software Version: NA Product Descript...

Due to packaging discrepancy with the incorrect tibial inserts/implants being packaged. Issued discovered via a customer complaint.

Class IIReported ongoing

Distribution: RFK Medical Inc. Viriginia (VA) CE102 952-28-40E 2224A1124A EMPOWR Acetabular, Dual Mobility, Poly Bearing, ID28, OD40 1 Valor Medical Solutions South Texas (TX) CE118 952-28-40...

Official source for Brand Name: EMPOWR Dual Mobility" Product Name: EMPOWR Acetabular, Dual Mobility, Poly Bearing, I...
FDA device enforcement

Brand Name: EMPOWR Dual Mobility" Product Name: EMPOWR Acetabular, Dual Mobility, Poly Bearing, ID28, OD42 Model/Catalog Number: 952-28-42F Software Version: NA Product Descript...

Due to packaging discrepancy with the incorrect tibial inserts/implants being packaged. Issued discovered via a customer complaint.

Class IIReported ongoing

Distribution: RFK Medical Inc. Viriginia (VA) CE102 952-28-40E 2224A1124A EMPOWR Acetabular, Dual Mobility, Poly Bearing, ID28, OD40 1 Valor Medical Solutions South Texas (TX) CE118 952-28-40...

Official source for Brand Name: EMPOWR Dual Mobility" Product Name: EMPOWR Acetabular, Dual Mobility, Poly Bearing, I...
FDA device enforcement

Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEETM INS, 11L 10MM, VE Model/Catalog Number: 341-10-711 Software Version: NA Product Description: Eno...

Due to packaging discrepancy with the incorrect tibial inserts/implants being packaged. The use of this product may result in the incorrect product being selected. This could result in a revision surgery if used.

Class IIReported ongoing

Distribution: U.S Distribution to states of: AZ, IA, ID, IL, IN, LA, MI, MO, MS, NE, NY, OK, OR, PR, SD, UT, VA, and WA

Official source for Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEETM INS, 11L 10MM, V...
FDA device enforcement

Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEETM INS, 11L 12MM, VE Model/Catalog Number: 341-12-711 Software Version: NA Product Description: Eno...

Due to packaging discrepancy with the incorrect tibial inserts/implants being packaged. The use of this product may result in the incorrect product being selected. This could result in a revision surgery if used.

Class IIReported ongoing

Distribution: U.S Distribution to states of: AZ, IA, ID, IL, IN, LA, MI, MO, MS, NE, NY, OK, OR, PR, SD, UT, VA, and WA

Official source for Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEETM INS, 11L 12MM, V...
FDA device enforcement

Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm Model/Catalog Number: 506-04-126 Software Version: NA Product Description: Encore Medical...

Package labeling for Altivate Reverse Torx Peripheral screw contains a different size then actual included product.

Class IIReported ongoing

Distribution: At time of quarantine: RFK Medical Inc. Virginia (VA) CE102 506-04-122 5035A1018 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 22mm 2 506-04-126 5037A1017 ALTIVATE REVERSE TORX PERIPH...

Official source for Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm Model/Cat...
FDA device enforcement

Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 22mm Model/Catalog Number: 506-04-122 Software Version: NA Product Description: Encore Medical...

Package labeling for Altivate Reverse Torx Peripheral screw contains a different size then actual included product.

Class IIReported ongoing

Distribution: At time of quarantine: RFK Medical Inc. Virginia (VA) CE102 506-04-122 5035A1018 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 22mm 2 506-04-126 5037A1017 ALTIVATE REVERSE TORX PERIPH...

Official source for Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 22mm Model/Cat...
FDA device enforcement

Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 18mm Model/Catalog Number: 506-04-118 Software Version: NA Product Description: Encore Medical...

Package labeling for Altivate Reverse Torx Peripheral screw contains a different size then actual included product.

Class IIReported ongoing

Distribution: At time of quarantine: RFK Medical Inc. Virginia (VA) CE102 506-04-122 5035A1018 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 22mm 2 506-04-126 5037A1017 ALTIVATE REVERSE TORX PERIPH...

Official source for Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 18mm Model/Cat...

Reasons in these listed records

  • Due to packaging discrepancy with incorrect product size mixed up.
  • Knee and Humeral socket implants contain incorrect labeling.
  • 942-01-40G acetabular system package was found to contain 942-01-36H acetabular system; and several other acetabular system and knee insert devices may also have a packaging discrepancy, which may cause surgical delay to exchange devices or revision surgery.
  • Their is a potential that the reamer may kick or bind up during or immediately prior to use.

These examples come from this result page and are not a ranking of every recall reason.

Checking Encore Medical, LP

Is there a recall on encore medical, lp right now?

This archive contains 43 records, including 41 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product.

How do I check my package or product?

Compare the product, firm and lot, date, model or serial identifiers with the notice. Use the label-check guide if you need help locating an identifier.

Does a matching name mean every item is included?

A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall.

What if the search finds no matching record?

This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. Check source coverage and the agency's current notices.

Where can I find older records?

Use monthly archives or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page.

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