—#122645

Product

Synthes Spiked Washers 13.5/6.5 Spiked Washers 13.5/6.5 are intended to be used in ligament reattachment or fixation, specifically readaptation of torn or avulsed ligaments.

FDA product code: HTN — Washer, Bolt Nut
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K011583
Affected lot / code info: part 219.951 with multiple lot#: 2335941 2339634 2397429 2405812 2440475 2442736 2496414 5661855 5663841

Why it was recalled

During a retrospective assessment, Spiked Washers 13.5/6.5 were discovered to be mislabeled as Spiked Washers 13.5/5.5.

Root cause (FDA determination)

Finished device change control

Action the firm took

SYNTHES sent an Urgent Notice: Medical Device Recall letter dated October 3, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed call Synthes at 1-800-479-6329 to obtain a Return Authorization Number, complete the Verification Section at the end of the letter by checking the appropriate box indicating affected product located. Return the Verification Form to: Credit/Returns Synthes 1101 Synthes Avenue, Monument, CO 80132 Customers were also asked to return the Verification Form indicating they did not have the affected product also. All documents were to be returned to Synthes by: Fax 1-877-270-5855 Scan/email: FieldAction@synthes.com Customers with questions were instructed to call 610-719-5450 or contact their Synthes Sales Consultant For questions regarding this recall call 610-719-5000..

Recalling firm

Firm: Synthes USA HQ, Inc.
Address: 1302 Wrights Ln E, West Chester, Pennsylvania 19380-3417

Distribution

Distribution pattern: Nationwide Distribution

Timeline

Recall initiated: 2013-10-03
Posted by FDA: 2013-11-26
Terminated: 2015-12-18
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #122645. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.