Howmedica Osteonics Corp. recall records

122 reported ongoing

124 records in this archive. Latest source date Jul 30, 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

HRIS ACET CUP CUT TIP 26X140 Part Number: 6210-5-100. single-use, sterile surgical instruments used during hip arthroplasty

Failed to meet the acceptance criteria for the seal integrity and/or package integrity testing for the Sterile Barrier Outer Pouch and the Protective Barrier Inner Pouch, compromising product sterility

Class IIReported ongoing

Distribution: Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Brazil, Canada, Chile, China (Hong Kong), Columbia, Italy, Japan, Malaysia, Netherlands (Venlo)...

Official source for HRIS ACET CUP CUT TIP 26X140 Part Number: 6210-5-100. single-use, sterile surgical instruments us...
FDA device enforcement

HRIS ACET CUP CUT TIP 32X140 Part Number: 6210-5-200rker. single-use, sterile surgical instruments used during hip arthroplasty

Failed to meet the acceptance criteria for the seal integrity and/or package integrity testing for the Sterile Barrier Outer Pouch and the Protective Barrier Inner Pouch, compromising product sterility

Class IIReported ongoing

Distribution: Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Brazil, Canada, Chile, China (Hong Kong), Columbia, Italy, Japan, Malaysia, Netherlands (Venlo)...

Official source for HRIS ACET CUP CUT TIP 32X140 Part Number: 6210-5-200rker. single-use, sterile surgical instrument...
FDA device enforcement

SCORPIO RECESSED PATELLA- Intended for Knee Replacement Part Number: 3044-0026

Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.

Class IIReported ongoing

Distribution: Nationwide Foreign: Argentina, Australia, Brazil, Canada, Chile, China, Columbia, India, Japan, Korea, Latin America, Mexico, Poland, Sweden, Switzerland, Taiwan, UK, & Venlo (N...

Official source for SCORPIO RECESSED PATELLA- Intended for Knee Replacement Part Number: 3044-0026
FDA device enforcement

SCORPIO RECESSED PATELLA- Intended for knee replacement Part Number: 3044-0028

Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.

Class IIReported ongoing

Distribution: Nationwide Foreign: Argentina, Australia, Brazil, Canada, Chile, China, Columbia, India, Japan, Korea, Latin America, Mexico, Poland, Sweden, Switzerland, Taiwan, UK, & Venlo (N...

Official source for SCORPIO RECESSED PATELLA- Intended for knee replacement Part Number: 3044-0028
FDA device enforcement

SCORPIO RECESSED PATELLA- Intended for knee replacement Part Number: 3044-0030

Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.

Class IIReported ongoing

Distribution: Nationwide Foreign: Argentina, Australia, Brazil, Canada, Chile, China, Columbia, India, Japan, Korea, Latin America, Mexico, Poland, Sweden, Switzerland, Taiwan, UK, & Venlo (N...

Official source for SCORPIO RECESSED PATELLA- Intended for knee replacement Part Number: 3044-0030
FDA device enforcement

SCORPIO RECESSED PATELLA-Intended for knee repalcment Part Number: 3044-0032

Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.

Class IIReported ongoing

Distribution: Nationwide Foreign: Argentina, Australia, Brazil, Canada, Chile, China, Columbia, India, Japan, Korea, Latin America, Mexico, Poland, Sweden, Switzerland, Taiwan, UK, & Venlo (N...

Official source for SCORPIO RECESSED PATELLA-Intended for knee repalcment Part Number: 3044-0032
FDA device enforcement

SERIES II TIBIAL BEAR INSERT-Intended for knee replacement Part Number: 3052-0515

Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.

Class IIReported ongoing

Distribution: Nationwide Foreign: Argentina, Australia, Brazil, Canada, Chile, China, Columbia, India, Japan, Korea, Latin America, Mexico, Poland, Sweden, Switzerland, Taiwan, UK, & Venlo (N...

Official source for SERIES II TIBIAL BEAR INSERT-Intended for knee replacement Part Number: 3052-0515
FDA device enforcement

SERIES II TIBIAL BEAR INSERT-Intended for knee replacement Part Number: 3052-0524

Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.

Class IIReported ongoing

Distribution: Nationwide Foreign: Argentina, Australia, Brazil, Canada, Chile, China, Columbia, India, Japan, Korea, Latin America, Mexico, Poland, Sweden, Switzerland, Taiwan, UK, & Venlo (N...

Official source for SERIES II TIBIAL BEAR INSERT-Intended for knee replacement Part Number: 3052-0524
FDA device enforcement

SCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-0321

Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.

Class IIReported ongoing

Distribution: Nationwide Foreign: Argentina, Australia, Brazil, Canada, Chile, China, Columbia, India, Japan, Korea, Latin America, Mexico, Poland, Sweden, Switzerland, Taiwan, UK, & Venlo (N...

Official source for SCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-0321
FDA device enforcement

SCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-0510

Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.

Class IIReported ongoing

Distribution: Nationwide Foreign: Argentina, Australia, Brazil, Canada, Chile, China, Columbia, India, Japan, Korea, Latin America, Mexico, Poland, Sweden, Switzerland, Taiwan, UK, & Venlo (N...

Official source for SCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-0510
FDA device enforcement

SCORPIO TS TIB INSERT-Intended for knee replacement Part Number:72-4-7512

Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.

Class IIReported ongoing

Distribution: Nationwide Foreign: Argentina, Australia, Brazil, Canada, Chile, China, Columbia, India, Japan, Korea, Latin America, Mexico, Poland, Sweden, Switzerland, Taiwan, UK, & Venlo (N...

Official source for SCORPIO TS TIB INSERT-Intended for knee replacement Part Number:72-4-7512
FDA device enforcement

SCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-7514

Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.

Class IIReported ongoing

Distribution: Nationwide Foreign: Argentina, Australia, Brazil, Canada, Chile, China, Columbia, India, Japan, Korea, Latin America, Mexico, Poland, Sweden, Switzerland, Taiwan, UK, & Venlo (N...

Official source for SCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-7514
FDA device enforcement

SCORPIO TS TIB INSERT -Intended for knee replacment Part Number: 72-4-7516

Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.

Class IIReported ongoing

Distribution: Nationwide Foreign: Argentina, Australia, Brazil, Canada, Chile, China, Columbia, India, Japan, Korea, Latin America, Mexico, Poland, Sweden, Switzerland, Taiwan, UK, & Venlo (N...

Official source for SCORPIO TS TIB INSERT -Intended for knee replacment Part Number: 72-4-7516
FDA device enforcement

SCORPIO TS TIB INSERT. Intended for knee replacement Part Number: 72-4-7518

Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.

Class IIReported ongoing

Distribution: Nationwide Foreign: Argentina, Australia, Brazil, Canada, Chile, China, Columbia, India, Japan, Korea, Latin America, Mexico, Poland, Sweden, Switzerland, Taiwan, UK, & Venlo (N...

Official source for SCORPIO TS TIB INSERT. Intended for knee replacement Part Number: 72-4-7518
FDA device enforcement

SCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-7521

Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.

Class IIReported ongoing

Distribution: Nationwide Foreign: Argentina, Australia, Brazil, Canada, Chile, China, Columbia, India, Japan, Korea, Latin America, Mexico, Poland, Sweden, Switzerland, Taiwan, UK, & Venlo (N...

Official source for SCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-7521

Reasons in these listed records

  • Potential packaging breaches of inner blister and outer sterile blister.
  • Failed to meet the acceptance criteria for the seal integrity and/or package integrity testing for the Sterile Barrier Outer Pouch and the Protective Barrier Inner Pouch, compromising product sterility
  • Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.

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

Checking Howmedica Osteonics Corp.

Is there a recall on howmedica osteonics corp. right now?

This archive contains 124 records, including 122 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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