Recall Z-2732-2024
Howmedica Osteonics Corp. · initiated August 5, 2024
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Custom Made Device - GMRS EXTENSION Piece 40MM LEFT, 35 Deg EXT Rotated Tabs (Patient Specific); Catalog Number: C-MM100434-00;
Codes / lots: Catalog Number: C-MM100434-00; Lot Number: HX2H9A;
Reason for recall
A patient specific, custom-made device was supplied for a surgical procedure that did not match the design proposal.
FDA-determined cause: Process control
Action taken
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
Details
- Recall number
- Z-2732-2024
- Initiated
- August 5, 2024
- Posted by FDA
- August 26, 2024
- Product code
- JDI – Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
- Quantity
- 1 unit (OUS only)
- Distribution
- International distribution to the country of Australia.
- Recalling firm
- Howmedica Osteonics Corp., Mahwah, NJ