The Oxford Partial Knee — Class II medical device recall Z-1127-2013
Terminated recall by Synvasive Technology Inc, reported 2013-04-24, distributed nationwide. Biomet part # 506076, lot 928182 was received from Synvasive Technology containing the incorrect blade.
| Recall number | Z-1127-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Synvasive Technology Inc, El Dorado Hills, CA, United States |
| Recall initiated | 2013-03-14 |
| Classified | 2013-04-16 |
| Reported by FDA | 2013-04-24 |
| Terminated | 2014-01-13 |
| Distributed | Nationwide (US) |
| Quantity | 100 kits |
| Lot numbers | 829182 |
| Model numbers | 11-3629 |
Product
The Oxford Partial Knee; Oxford Knee Resection Procedure 3 Pack CEMENTED For use with Stryker System 5, System 4, System 2000 and EDH. Product Usage: For use with Stryker System 5, System 4, System 2000 and EDH. A set of three surgical saw blades is used to resect damaged cartilage and/or bone in an orthopedic reconstructive procedure such as a partial knee replacement. The set contains both oscillating blades for tissue resection along a small arc in a left/right or up/down direction, and reciprocating blades for resection back and forth in a single plane.
Reason for recall
Biomet part # 506076, lot 928182 was received from Synvasive Technology containing the incorrect blade.
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-1127-2013. 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.