Enforcement Report - Week of October 24, 2012
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Product Detail
| Product Description | "***PressFT***2.1 w/ One #2 (5 metric) Hi-Fi***Suture***NP211***2009-02***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA*** To reattach soft tissue to bone in orthopedic surgical procedures |
|---|---|
| Recall Number | Z-0067-2013 |
| Classification | Class II |
| Code Info | Item number NP211 |
| Product Distributed Qty | 879 units for all products in recall event |
| Reason For Recall | 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. |
Event Detail
| Event Id | 63115 |
|---|---|
| Product Type | Devices |
| Status | Ongoing |
| Recalling Firm | Linvatec Corp. dba ConMed Linvatec |
| City | Largo |
| State | FL | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-06-26 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | Worldwide Distribution - USA including AZ, CA, CO, FL, GA, LA, MA, ME, MI, MN, NJ, NM, NY, PA, TX, UT, and WA. Internationally to BE, CA, ES, MY, NZ and PL |
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