—#117661

Product

Synthes 3.5 MM LCP(R) Distal Humerus System The Synthes 3.5 MM LCP Distal Humerus System is intended for fixation of fractures of the distal humerus, olecranon, and ulna in adults and adolescents (12-21) in which the growth plates have fused. Specifically, distal humerus plates are indicated for intra-articular fractures, comminuted supracondylar fractures, osteotomies, malunions and non-unions of the distal humerus.

FDA product code: KTT — Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K033995
Affected lot / code info: Part Number 241.267, lot number 8037923

Why it was recalled

Recall is being initiated due to the part being mislabeled (Part Number 241.267 was mislabeled with Part Number 241.276).

Root cause (FDA determination)

Labeling mix-ups

Action the firm took

Synthes sent an Urgent Notice Medical Device Recall letter dated March 8, 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 obtain a Return Authorization Number, complete the Verification Section at the end of the letter by the checking the appropriate box indicating affected product located. Return the Verification Form with the product to: Credit/Returns, Synthes, 1101 Synthes Avenue, Monument, CO 80132. Customers with questions were instructed to call 610-719-5450 or email Fieldaction@synthes.com. 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 including CA,and VA. .

Timeline

Recall initiated: 2013-03-08
Posted by FDA: 2013-09-25
Terminated: 2015-05-21
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #117661. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.