FDA Device

Stryker Peek Intraline Anchor, 5.5 mm, Model number 3910-400-010 Used for tissue fixation to bone in certain areas.

Hazard

Product package may crack and cause loss of sterility.

What You Should Do

Remedy

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.

Products

Stryker Peek Intraline Anchor, 5.5 mm, Model number 3910-400-010 Used for tissue fixation to bone in certain areas.
Brand
Stryker Endoscopy
UPC
Lot numbers 07276AE2, 07295AE2, 07296AE2, 07299AE2, 07312AE2

Units Affected

355 units