Recall Z-1537-2008 ยท MBI Fastener, Fixation, Nondegradable, Soft Tissue
Stryker Endoscopy
Stryker Wedge HS Suture Anchor II with Needles, 5.0 mm, Model number 3910-100-135. Intended for use in securing soft tissue to bone in certain procedures in specific areas.
| Date | Aug 6, 2008 (initiated Feb 7, 2008) |
| Status | Terminated |
| Reason | Product package may crack and cause loss of sterility. |
| Root cause | Packaging |
| 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. |
| Quantity | 57 units |
| Distribution | Product was distributed to 8 consignees in CA, OH, PA, CO, MA, and NJ. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K983557 | STRYKER WEDGE SUTURE ANCHOR Stryker Endoscopy, Dec 18, 1998 |