—#68500

Product

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.

FDA product code: MBI — Fastener, Fixation, Nondegradable, Soft Tissue
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K983557
Affected lot / code info: Lot number 07298AE2, 07299AE2

Why it was recalled

Product package may crack and cause loss of sterility.

Root cause (FDA determination)

Packaging

Action the firm took

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.

Recalling firm

Firm: Stryker Endoscopy
Address: 5900 Optical Ct, San Jose, California 95138

Distribution

Distribution pattern: Product was distributed to 8 consignees in CA, OH, PA, CO, MA, and NJ.

Timeline

Recall initiated: 2008-02-07
Posted by FDA: 2008-08-06
Terminated: 2010-12-21
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #68500. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.