ConMed Linvatec Biomaterials — Class II medical device recall Z-0789-2013
Terminated recall by Linvatec Corp. dba ConMed Linvatec, reported 2013-02-13, distributed in CA. ConMed Linvatech recalled one lot of their PopLok bone Punch 3.5mm because the metal shaft diameter is 4.5mm w
| Recall number | Z-0789-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Linvatec Corp. dba ConMed Linvatec, Largo, FL, United States |
| Recall initiated | 2012-11-15 |
| Classified | 2013-02-05 |
| Reported by FDA | 2013-02-13 |
| Terminated | 2013-05-22 |
| Distributed | CA |
| Countries outside the US | ES, KR |
| Quantity | 8 |
| Lot numbers | 256058 |
Product
ConMed Linvatec Biomaterials, PopLok bone Punch PKL-35M, 3.5mm Orthopedic manual surgical instrument - Bone Punch
Reason for recall
ConMed Linvatech recalled one lot of their PopLok bone Punch 3.5mm because the metal shaft diameter is 4.5mm when it should be 3.5mm.
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-0789-2013. 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.