PopLok Punch labeled in part: "PKL-35M***3 — Class II medical device recall Z-2151-2012
Terminated recall by Linvatec Corp. dba ConMed Linvatec, reported 2012-08-15. ConMed Linvatec recalled one lot of their PopLok bone Punch 3.5MM because the metal shaft diameter is 4.5mm wh
| Recall number | Z-2151-2012 |
|---|---|
| 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 | 2012-07-06 |
| Classified | 2012-08-06 |
| Reported by FDA | 2012-08-15 |
| Terminated | 2013-11-21 |
| Countries outside the US | KR |
| Quantity | 2 |
| Lot numbers | 318455 |
Product
PopLok Punch labeled in part: "PKL-35M***3.5mm***QTY 1***PopLok Punch***ConMed Linvatec Biomaterials, Ltd. Hermiankatu 6-8L 33720 Tampere, FINLAND***Rx Only***ConMed Linvatec 11311 Concept Blvd Largo, FL 33773-4908 USA***Made in USA***" Intended Use: Bone Punch.
Reason for recall
ConMed Linvatec recalled one lot of their PopLok bone Punch 3.5MM because the metal shaft diameter is 4.5mm when it should have been 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-2151-2012. 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.