OPUS SpeedStitch Suture Cartridge with Magnumwire, a component of the OPUS MiniPlus Implant Set, for use in placement of sutures through soft tissue in endoscopic and other limited access procedures.
- Company
- Arthrocare Corporation
- Recall Initiated
- June 28, 2006
- Posted
- August 2, 2006
- Terminated
- December 5, 2007
- Recall Number
- Z-1312-06
- Quantity
- 198 units
- Firm Location
- Sunnyvale, CA
Reason for Recall
The product may lose sterility due to omission of the final pouch seal.
Distribution
Nationwide.
Lot / Code Info
All products consisting of lot number 110399, Catalog number OM-6006. This catalog number is referred to as the OPUS MiniPlus Implant Set.
Root Cause
Packaging process control
Action Taken
The firm has issued notification letters to all customers in the United States on June 29, 2006 via overnight delivery, advising customers to return all product with incomplete or missing seals to Arthocare.
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