Recall Z-2147-2012— Linvatec Corp. dba ConMed Linvatec
Class II · Terminated
Class II FDA medical device recall by Linvatec Corp. dba ConMed Linvatec, initiated 2011-08-12, terminated 2013-11-21. FDA's recall record names no specific 510(k) clearance for this event. Product: CrossFT Punch, Product Number PFT-45M. Manufacturer: CONMED LINVATEC. The intended use is to create a hole to facilitate insertion of the CrossFT suture anchor into bone.. Reason: ConMed Linvatec recalled lot number #156920, PFT-45M, CrossFT Punch because there is a possibility that the device was etched incorrectly listing the item number as PFT-00M and includes incorrect depth lines for insertion..
- Recalling firm
- Linvatec Corp. dba ConMed Linvatec
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2011-08-12
- Terminated
- 2013-11-21
- Firm location
- Largo, FL, United States
Product description
CrossFT Punch, Product Number PFT-45M. Manufacturer: CONMED LINVATEC. The intended use is to create a hole to facilitate insertion of the CrossFT suture anchor into bone.
Reason for recall
ConMed Linvatec recalled lot number #156920, PFT-45M, CrossFT Punch because there is a possibility that the device was etched incorrectly listing the item number as PFT-00M and includes incorrect depth lines for insertion.
Data sourced from openFDA. This site is unofficial and independent of the FDA.