FDA Recall Terminated

Synthes 14.5 mm Outer Protection Sleeve for Suprapatellar Synthes 14.5 mm Outer Protection Sleeve for Suprapatellar is used as part of the Synthes Tibial Nail System EX to stabilize fractures of the proximal and distal tibia and the tibia shaft, open and closed tibia shaft fractures, certain pre- and post- isthmic fractures, and tibial malunions and non-unions.

Recall: Z-0404-2014 · Initiated October 14, 2013

Recall

Recall Number: Z-0404-2014
Event Number: 66581
Firm: Synthes (USA) Products LLC
FEI Number: 3008812560
Product Code: JDS
Status: Terminated
Root Cause: Labeling mix-ups
Initiated: October 14, 2013
Posted: November 26, 2013
Terminated: August 18, 2015
Address: 1301 Goshen Pkwy, West Chester, PA, 19380-5986

Description

Reason

Complaints were received reporting that a product packaged as a 14.5 mm Outer Protection Sleeve for Suprapatellar contained a 12.0 mm Outer Protection Sleeve for Suprapatellar.

Action

Synthes sent an Urgent Notice: Medical Device Recall letter dated October 14, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to call Synthes at 1-800-479-6329 if they have any of the affected product to obtain a Return Authorization Number, complete the Verification Section at the end of the letter and return the Verification Form with the affected product to: Credit/Returns Synthes 1101 Synthes Avenue Monument, CO 80132 If customers do not have the affected product they should complete the attached Verification Section and return all documents to Synthes by: Fax: 866-229-7778 Scan/email: [email protected] Customers with questions were instructed to call 610-719-5450. For questions regarding this recall call 610-719-5000.

Distribution

Nationwide Distribution

Quantity