Linvatec Corp. dba ConMed Linvatec

FDA Regulatory Profile

Summary

Total Recalls
21
510(k) Clearances
0
Inspections
6
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1680-2013Class II***REF C7120***APEX Arthroscopy Tubing Set. Intended for use for joint irrigation and dissention May 30, 2013
Z-1681-2013Class II***REF C7122***QTY 1***APEX Arthroscopy Tubing Set. Intended for use for joint irrigation and disMay 30, 2013
Z-1340-2013Class IIRef: VP1600 HD Still Capture System ConMed Linvatec . Captures, stores and transfers images genMarch 18, 2013
Z-1619-2013Class IIGENESYS Cross FT Suture Anchor with Two #2 (5 metric) Hi-FI Registered Trade Mark Sutures Rx Only STMarch 6, 2013
Z-0917-2013Class IIID3000I Advantage Drive System, 230v, surgical instrument motor. Product Usage: The Advantage DriJanuary 24, 2013
Z-0916-2013Class IIID3000 Advantage Drive System, 115v Product Usage: The Advantage Drive Systems function as a powJanuary 24, 2013
Z-0789-2013Class IIConMed Linvatec Biomaterials, PopLok bone Punch PKL-35M, 3.5mm Orthopedic manual surgical insNovember 15, 2012
Z-2151-2012Class IIPopLok Punch labeled in part: "PKL-35M***3.5mm***QTY 1***PopLok Punch***ConMed Linvatec BiomaterialJuly 6, 2012
Z-0064-2013Class II"***PressFT***2.6 w/ One #2 (5 metric) Hi-Fi***Suture***NP261***2009-02***CONMED LINVATEC 11311 CONCJune 26, 2012
Z-0068-2013Class IINP211H***2009-02***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA*** To reattach sofJune 26, 2012
Z-0067-2013Class II"***PressFT***2.1 w/ One #2 (5 metric) Hi-Fi***Suture***NP211***2009-02***CONMED LINVATEC 11311 CONCJune 26, 2012
Z-0066-2013Class II"***PressFT***2.1 w/ Two #0 (3.5 metric) Hi-Fi***Sutures***NP212***2009-02***CONMED LINVATEC 11311 CJune 26, 2012
Z-0065-2013Class II"***Press FT***2.6 w/ One #2 (5 metric) Hi-Fi***Suture, HIP***N2***2009-02***CONMED LINVATEC 11311 CJune 26, 2012
Z-0063-2013Class II"***PressFT***2.6 w/ Two #1 (4 metric) Hi-Fi***Sutures***NP262***2009-02***CONMED LINVATEC 11311 CONJune 26, 2012
Z-0384-2013Class II"***SENTINEL***Cannulated Drill Bit***S8585***8.5 X 229mm (9")***CONMED LINVATEC 11311 CONCEPT BLVD April 10, 2012
Z-0383-2013Class II"***SENTINEL***Cannulated Drill Bit***S8580***8 X 229mm (9")***CONMED LINVATEC 11311 CONCEPT BLVD LAApril 10, 2012
Z-0164-2013Class II"***All in one CrossFT***Punch***PFT-00M***4.5mm to 6.5mm***CONMED LINVATEC 11311 CONCEPT BLVD LARGOApril 9, 2012
Z-2147-2012Class IICrossFT Punch, Product Number PFT-45M. Manufacturer: CONMED LINVATEC. The intended use is to creatAugust 12, 2011
Z-2469-2012Class IICatheter Irrigation Set labeled in part: ***24K Arthroscopy Outflow/Suction Tubing Set*** This ArJuly 1, 2011
Z-2456-2012Class II***REF LS7700***Qty 1*** EC REP*** ConMed Linvatec Xenon Universal Light SourceMay 20, 2011