—#122646

Product

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.

FDA product code: JDS — Nail, Fixation, Bone
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K111667
Affected lot / code info: part no. 03010.438S, lot 706802

Why it was recalled

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.

Root cause (FDA determination)

Labeling mix-ups

Action the firm took

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: FieldAction@synthes.com Customers with questions were instructed to call 610-719-5450. For questions regarding this recall call 610-719-5000.

Recalling firm

Firm: Synthes (USA) Products LLC
Address: 1301 Goshen Pkwy, West Chester, Pennsylvania 19380-5986

Distribution

Distribution pattern: Nationwide Distribution

Timeline

Recall initiated: 2013-10-14
Posted by FDA: 2013-11-26
Terminated: 2015-08-18
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #122646. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.