Custom Made Device - GMRS EXTENSION Piece 40MM LEFT, 35 Deg… recallZ-2732-2024 · Howmedica Osteonics Corp. · initiated Aug 5, 2024
Class II Open, Classified All recalls posted in August 2024
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Howmedica Osteonics Corp. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
A patient specific, custom-made device was supplied for a surgical procedure that did not match the design proposal.
FDA root cause category: Process control
What the company is doing
On August 5, 2024 an URGENT MEDICAL DEVICE RECALL letter was sent to their consignee. Actions Needed: Our records indicate that you have received the affected product, and that product has already been returned to Stryker. We therefore request that you read this notice carefully and complete the following actions. 1. Complete and sign the enclosed Urgent Medical Device Recall Business Reply Form. Please assist us in meeting our regulatory obligation by emailing back the attached Urgent Medical Device Recall Business Reply Form within 5 days. We regret any inconvenience this action may cause. For questions pertaining to the recall, please email [email protected]
Recall details
- Recall number
- Z-2732-2024
- Recall class
- Class II
- Status
- Open, Classified
- Initiated by the company
- Aug 5, 2024
- Posted by the FDA
- Aug 26, 2024
- Recalling firm
- Howmedica Osteonics Corp.
- Quantity
- 1 unit (OUS only)
- Product code
- JDI
- FDA submissions
- K023087, K222056
- Distribution
- International distribution to the country of Australia.
Product description
Custom Made Device - GMRS EXTENSION Piece 40MM LEFT, 35 Deg EXT Rotated Tabs (Patient Specific); Catalog Number: C-MM100434-00;
Code information (models, lots, serial numbers)
Catalog Number: C-MM100434-00; Lot Number: HX2H9A;
Other devices under the same FDA submission
30 devices cleared under K023087, K222056 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- GMRS 6495-2-040Howmedica Osteonics Corp. · PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER15 reports
- GMRS 6495-2-010Howmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, metal/polymer, cemented13 reports
- GMRS 6495-2-020Howmedica Osteonics Corp. · PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER10 reports
- GMRS 6495-2-030Howmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, metal/polymer, cemented7 reports
- GMRS 6495-1-001Howmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, metal/polymer, cemented5 reports
- GMRS 6495-2-105Howmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, metal/polymer, cemented5 reports
- GMRS 6495-6-040Howmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, metal/polymer, cemented5 reports
- GMRS 6495-6-080Howmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, metal/polymer, cemented5 reports
- GMRS 6495-3-010Howmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, metal/polymer, cemented4 reports
- GMRS 6495-3-102Howmedica Osteonics Corp. · PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER4 reports
- GMRS 6495-5-011Howmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented3 reports
- GMRS 6495-1-201Howmedica Osteonics Corp. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED3 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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