[Recalled] ConMed Linvatec Biomaterials, PopLok bone Punch PKL-35M, 3.5mm Orthopedic manual surgical instrument - Bone Punch — ConMed Linvatech recalled one lot of their PopLok bone Punch 3.5mm because the… | FDA 2012-11-15
Authorities recorded a safety problem with this product. The details below come directly from the government recall notice.
Recall details
| Product | ConMed Linvatec Biomaterials, PopLok bone Punch PKL-35M, 3.5mm Orthopedic manual surgical instrument - Bone Punch |
|---|---|
| Brand / manufacturer | Linvatec Corp. dba ConMed Linvatec |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-0789-2013 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 15 November 2012 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: 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.
This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Check whether your unit is affected and follow the authority's guidance before further use.
Read the full official notice →
Related recalls from Linvatec Corp. dba ConMed Linvatec
This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.