FDA Medical Device Recalls (openFDA)
Howmedica Osteonics Corp.: Custom Made Device - GMRS EXTENSION Piece 40MM LEFT, 35 Deg EXT Rotated Tabs (Patient Specific); Catalog Number: C-MM100434-00;
- Recall number
- Z-2732-2024
- Recalling firm
- Howmedica Osteonics Corp.
- Product
- Custom Made Device - GMRS EXTENSION Piece 40MM LEFT, 35 Deg EXT Rotated Tabs (Patient Specific); Catalog Number: C-MM100434-00;
- Status
- Open, Classified
- Initiated
- 2024-08-05
- Posted
- 2024-08-26
- Terminated
- not on file
- Reason
- A patient specific, custom-made device was supplied for a surgical procedure that did not match the design proposal.
- Root cause
- Process control
- Action
- 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 SO_M_PRODUCT_FIELD_ACTION_RESPONSE@stryker.com
- Quantity
- 1 unit (OUS only)
- Distribution
- International distribution to the country of Australia.
- Lot, serial or model codes
- Catalog Number: C-MM100434-00; Lot Number: HX2H9A;
- 510(k) numbers
- ["K023087","K222056"]
- PMA numbers
- not on file
- Product code
- JDI
- Firm FEI
- 3003070421
- Firm city
- Mahwah
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28