Stryker Orthopaedics Rim Impactor Tip Product Usage: Used for MDM… — Class II medical device recall Z-0582-2014
Terminated recall by Stryker Howmedica Osteonics Corp., reported 2014-01-01, distributed nationwide. Stryker has received complaints associated with cracks and/or fracture of the Ball Impactor Tip and Rim Impact
| Recall number | Z-0582-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stryker Howmedica Osteonics Corp., Mahwah, NJ, United States |
| Recall initiated | 2013-09-30 |
| Classified | 2013-12-26 |
| Reported by FDA | 2014-01-01 |
| Terminated | 2016-10-19 |
| Distributed | Nationwide (US) |
| Quantity | 1,690 units |
| Reason classes | packaging, device malfunction |
| Model numbers | 12350-013 |
Product
Stryker Orthopaedics Rim Impactor Tip Product Usage: Used for MDM surgery.
Reason for recall
Stryker has received complaints associated with cracks and/or fracture of the Ball Impactor Tip and Rim Impactor Tip Instruments.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0582-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.