"***All in one CrossFT***Punch***PFT-00M***4 — Class II medical device recall Z-0164-2013
Terminated recall by Linvatec Corp. dba ConMed Linvatec, reported 2012-11-07, distributed nationwide. ConMed Linvatec is recalling the product due to the punch being mis-assembled with the incorrect handled. The
| Recall number | Z-0164-2013 |
|---|---|
| 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 | 2012-04-09 |
| Classified | 2012-10-29 |
| Reported by FDA | 2012-11-07 |
| Terminated | 2013-11-21 |
| Distributed | Nationwide (US) |
| Countries outside the US | TH |
| Quantity | 2 units |
| Lot numbers | 330889 |
| Model numbers | PFT-00M |
Product
"***All in one CrossFT***Punch***PFT-00M***4.5mm to 6.5mm***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA***" To create pathway for insertion of CrossFT Suture Anchor into bone.
Reason for recall
ConMed Linvatec is recalling the product due to the punch being mis-assembled with the incorrect handled. The correct handle is a clear anodized silver colored handle.
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-0164-2013. 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.