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Synthes 3.5 MM LCP(R) Distal Humerus System recallZ-2278-2013 · Synthes USA HQ, Inc. · initiated Mar 8, 2013

Class II Terminated All recalls posted in September 2013

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Synthes USA HQ, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

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).

FDA root cause category: Labeling mix-ups

What the company is doing

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.

Recall details

Recall number
Z-2278-2013
Recall class
Class II
Status
Terminated
Initiated by the company
Mar 8, 2013
Posted by the FDA
Sep 25, 2013
Recalling firm
Synthes USA HQ, Inc.
Quantity
2
Product code
KTT
FDA submissions
K033995
Distribution
Nationwide Distribution including CA,and VA. .

Product 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.

Code information (models, lots, serial numbers)

Part Number 241.267, lot number 8037923

Other devices under the same FDA submission

26 devices cleared under K033995 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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