[Recalled] NP211H***2009-02***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA*** To reattach soft tissue to bone in orthopedic surgical procedures — Linvatec Corporation dba ConMed Linvatec in Largo, FL is recalling PressFT H
Regulators flagged this product in an official safety action. Here is what the notice says and what it means for owners.
Recall details
| Product | NP211H***2009-02***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA*** To reattach soft tissue to bone in orthopedic surgical procedures |
|---|---|
| Brand / manufacturer | Linvatec Corp. dba ConMed Linvatec |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-0068-2013 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 26 June 2012 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: Linvatec Corporation dba ConMed Linvatec in Largo, FL is recalling PressFT HI-FI Sutures (items NP211, NP212, NP261, NP262, NP211H, NP261H-all lot numbers) due to the potential for the distal tip of the driver to become separated from the driver shaft after successful insertion of the implant.
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.