FDA Recall
Terminated
Stryker Peek Intraline Anchor, 6.5 mm, Model number 3910-400-020 Used for tissue fixation to bone in certain areas.
Recall: Z-1535-2008
·
Initiated February 7, 2008
Recall
- Recall Number
- Z-1535-2008
- Event Number
- 46916
- Firm
- Stryker Endoscopy
- FEI Number
- 2936485
- Product Code
- HWC
- Status
- Terminated
- Root Cause
- Packaging
- Initiated
- February 7, 2008
- Posted
- August 6, 2008
- Terminated
- December 21, 2010
- Address
- 5900 Optical Ct, San Jose, CA, 95138
Description
Stryker Peek Intraline Anchor, 6.5 mm, Model number 3910-400-020 Used for tissue fixation to bone in certain areas.
Reason
Product package may crack and cause loss of sterility.
Action
Stryker Endoscopy initiated the recall on 02/07/2008 by notifying its consignees via telephone, as well as sending out Urgent: Device Removal notices. Recipients of affected lots are to inspect their inventory for part/lot numbers and quarantine any affected product. Affected products are to be returned to Stryker Endoscopy and Customer Service should be contacted for replacement alternatives. Also, the "Acknowledgment of recipt" card needs to be signed and returned to Stryker Endoscopy.
Distribution
Product was distributed to 8 consignees in CA, OH, PA, CO, MA, and NJ.
Quantity
146 units