Device product
- ConMed Linvatec Spectrum II Suture Hook Crescent, Medium (Teal) 4.0 x 20.0mm. REF C6386 Lot 122592. - Arthrex SutureLasso SD, 25 Degree Tight Curve Left, Wire Loop, (Green) 1.8mm. REF AR-4068-25TL Lot 122518 and Lot 123190. -- Arthrex SutureLasso SD, 25 Degree Tight Curve Right, w/Nitinol Wire Loop, (Lt. Green) 1.8mm. REF AR-4068-25TR Lot 122518 and Lot 123190. - Arthrex SutureLasso SD, 90 Degrees (Black) 1.8mm. REF AR-4068-90 Lot 122504. - Arthrex SutureLasso, 45 Degree, Perforating Needle Cannula, w/Suture Loop, (Lt. Grey). REF AR-4065S Lot 122590. -SutureLasso, w/Wire Loop, 90 Degree, (Blue) REF AR-4065-90W Lot 123263. Manual surgical instrument for general use
Z-1624-2013
Product summary
- Event
- Event 65205
- Status
- Terminated
- Classification
- Class II
- Quantity
- 15
- Official record key
device-enforcement:Z-1624-2013
Official wording
Reason: The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch.
Code information: 122504; 122518; 122504; 122590; 122592; 123190; 123263.
Distribution pattern: Nationwide Distribution.
Derived failure modes
-
Sterility assurance
sterile barrier for reprocessed medical devices became compromised