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.
Recall
- Recall Number
- Z-2278-2013
- Event Number
- 65009
- Firm
- Synthes USA HQ, Inc.
- FEI Number
- 3005180112
- Product Code
- KTT
- Status
- Terminated
- Root Cause
- Labeling mix-ups
- Initiated
- March 8, 2013
- Posted
- September 25, 2013
- Terminated
- May 21, 2015
- Address
- 1302 Wrights Ln E, West Chester, PA, 19380-3417
Description
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.
Recall is being initiated due to the part being mislabeled (Part Number 241.267 was mislabeled with Part Number 241.276).
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 [email protected]. For questions regarding this recall call 610-719-5000.
Nationwide Distribution including CA,and VA. .
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