is it on recall

Home / Brand archive

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

UNITRAX Endoprosthesis Head Component - 43mm. Implantable component used in partial hip arthroplasty. Catalog Number: 6942-5-043

Mislabeled: the size on the package label of the UNITRAX¿ Endoprosthesis Head Component potentially may not match the device within the packaging. This product mix only involves the three (3) sizes (43mm, 42mm, and the 38mm)

Class IIReported ongoing

Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Hong Kong, and UK.

Official source
FDA device enforcement

UNITRAX Endoprosthesis Head Component - 42mm. Implantable component used in partial hip arthroplasty. Catalog Number: 6942-5-042

Mislabeled: the size on the package label of the UNITRAX¿ Endoprosthesis Head Component potentially may not match the device within the packaging. This product mix only involves the three (3) sizes (43mm, 42mm, and the 38mm)

Class IIReported ongoing

Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Hong Kong, and UK.

Official source
FDA device enforcement

UNITRAX Endoprosthesis Head Component - 38mm. Implantable component used in partial hip arthroplasty. Catalog Number: 6942-5-038

Mislabeled: the size on the package label of the UNITRAX¿ Endoprosthesis Head Component potentially may not match the device within the packaging. This product mix only involves the three (3) sizes (43mm, 42mm, and the 38mm)

Class IIReported ongoing

Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Hong Kong, and UK.

Official source
FDA device enforcement

HRIS Storage & Sterilization Case and Tray, Catalog/Part Number: 6210-9-900

The design of the HRIS Storage & Sterilization Case and Tray P/N 6210-9-900 and the Gray Revision Instrument System Accessory Tray/Case P/N 6210-9-910 may lead to misuse of the Gray Revision Instruments including re-use and re-sterilization of the single-us...

Class IIReported ongoing

Distribution: Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Brazil, Canada, Chile, Denmark, Hong Kong, Iran, Italy, Japan, Kuwait, Mexico, New Zealand, Sin...

Official source
FDA device enforcement

Gray Revision Instrument System Accessory Tray/Case, Catalog/Part Number: 6210-9-910

The design of the HRIS Storage & Sterilization Case and Tray P/N 6210-9-900 and the Gray Revision Instrument System Accessory Tray/Case P/N 6210-9-910 may lead to misuse of the Gray Revision Instruments including re-use and re-sterilization of the single-us...

Class IIReported ongoing

Distribution: Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Brazil, Canada, Chile, Denmark, Hong Kong, Iran, Italy, Japan, Kuwait, Mexico, New Zealand, Sin...

Official source
FDA device enforcement

TRIDENTII HEMI CLUSTER44B- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 702-11-44B

The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell

Class IIReported ongoing

Distribution: Nationwide Foreign: Netherlands, Canada, Singapore, Spain, Sweden, UK

Official source
FDA device enforcement

TRIDENTII HEMI CLUSTER48D-indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 702-11-48D

The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell

Class IIReported ongoing

Distribution: Nationwide Foreign: Netherlands, Canada, Singapore, Spain, Sweden, UK

Official source
FDA device enforcement

TRIDENTII HEMI CLUSTER50D- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 702-11-50D

The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell

Class IIReported ongoing

Distribution: Nationwide Foreign: Netherlands, Canada, Singapore, Spain, Sweden, UK

Official source
FDA device enforcement

TRIDENTII HEMI CLUSTER52E-Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 702-11-52E

The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell

Class IIReported ongoing

Distribution: Nationwide Foreign: Netherlands, Canada, Singapore, Spain, Sweden, UK

Official source
FDA device enforcement

TRIDENTII HEMI CLUSTER54E- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 702-11-54E

The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell

Class IIReported ongoing

Distribution: Nationwide Foreign: Netherlands, Canada, Singapore, Spain, Sweden, UK

Official source
FDA device enforcement

TRIDENTII HEMI CLUSTER58F- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 702-11-58F

The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell

Class IIReported ongoing

Distribution: Nationwide Foreign: Netherlands, Canada, Singapore, Spain, Sweden, UK

Official source
FDA device enforcement

TRIDENTII HEMI CLUSTER66H- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 702-11-66H

The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell

Class IIReported ongoing

Distribution: Nationwide Foreign: Netherlands, Canada, Singapore, Spain, Sweden, UK

Official source
FDA device enforcement

TRIDENTII PSL CLUSTER48D- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 742-11-48D

The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell

Class IIReported ongoing

Distribution: Nationwide Foreign: Netherlands, Canada, Singapore, Spain, Sweden, UK

Official source
FDA device enforcement

TRIDENTII PSL CLUSTER50D- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 742-11-50D

The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell

Class IIReported ongoing

Distribution: Nationwide Foreign: Netherlands, Canada, Singapore, Spain, Sweden, UK

Official source
FDA device enforcement

TRIDENTII PSL CLUSTER52E- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 742-11-52E

The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell

Class IIReported ongoing

Distribution: Nationwide Foreign: Netherlands, Canada, Singapore, Spain, Sweden, UK

Official source
FDA device enforcement

TRIDENTII PSL CLUSTER64H- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 742-11-64H

The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell

Class IIReported ongoing

Distribution: Nationwide Foreign: Netherlands, Canada, Singapore, Spain, Sweden, UK

Official source

Reasons in these listed records

  • Mislabeled: the size on the package label of the UNITRAX¿ Endoprosthesis Head Component potentially may not match the device within the packaging. This product mix only involves the three (3) sizes (43mm, 42mm, and the 38mm)
  • The design of the HRIS Storage & Sterilization Case and Tray P/N 6210-9-900 and the Gray Revision Instrument System Accessory Tray/Case P/N 6210-9-910 may lead to misuse of the Gray Revision Instruments including re-use and re-sterilization of the single-use, sterile-packaged ...
  • The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell
  • Potential packaging breaches of inner blister and outer sterile blister.

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.

Keep checking

Search Howmedica Osteonics Corp.Browse related productsReview source dates