Recalls / —

—#68493

Product

Stryker Peek Intraline Anchor, 6.5 mm, Model number 3910-400-020 Used for tissue fixation to bone in certain areas.

FDA product code

HWC — Screw, Fixation, Bone

Device class

Class 2

Medical specialty

Orthopedic

510(k) numbers

K071157

Affected lot / code info

Lot numbers 07276AE2, 07299AE2, 07311AE2

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 #68493. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.