Recall Z-1535-2008 ยท HWC Screw, Fixation, Bone
Stryker Endoscopy
Stryker Peek Intraline Anchor, 6.5 mm, Model number 3910-400-020 Used for tissue fixation to bone in certain 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 | 146 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
| K071157 | STRYKER PEEK AND TITANIUM SOFT EYELET ANCHORS Stryker Endoscopy, Sep 17, 2007 |