Synthes Spiked Washers 13.5/6.5 Spiked Washers 13.5/6.5 are intended to be used in ligament reattachment or fixation, sp

FDA device recall Z-0394-2014 · posted 2013-11-26 · Terminated

Recall details

Recalling firm

Synthes USA HQ, Inc.

Reason for recall

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

Action taken

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..

Root cause

Finished device change control

Status

Terminated

Product code

HTN

Quantity affected

3087

Distribution

Nationwide Distribution

Date initiated

2013-10-03

Date posted

2013-11-26

Date terminated

2015-12-18

Location

West Chester, PA

Related 510(k) clearances