Stryker Wedge HS Suture Anchor II with Needles, 6.5 mm, Model number 3910-100-145 Intended for use in securing soft tiss
FDA device recall Z-1538-2008 · posted 2008-08-06 · Terminated
Recall details
- Recalling firm
- Stryker Endoscopy
- Reason for recall
- Product package may crack and cause loss of sterility.
- Action taken
- 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.
- Root cause
- Packaging
- Status
- Terminated
- Product code
- MBI
- Quantity affected
- 53 units
- Distribution
- Product was distributed to 8 consignees in CA, OH, PA, CO, MA, and NJ.
- Date initiated
- 2008-02-07
- Date posted
- 2008-08-06
- Date terminated
- 2010-12-21
- Location
- San Jose, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| STRYKER WEDGE SUTURE ANCHOR (K983557) | Stryker Endoscopy | 1998-12-18 |