Z-2278-2013Class II

Synthes 3.5 MM LCP(R) Distal Humerus System The Synthes 3.5 MM LCP Distal Humerus System is intended for...

Name: Z-2278-2013 Synthes 3.5 MM LCP(R) Distal Humerus System The Synthes 3.5 MM LCP Distal Humerus System is intended for...
Creator: Synthes USA HQ, Inc.
Published: 2013-03-08
License: https://open.fda.gov/license/

Synthes GmbH / initiated 2013-03-08 / Terminated / root cause: labeling and UDI

FDA source

Synthes USA HQ, Inc. began a recall of 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... on 2013-03-08. FDA classified it as Class II and gives the reason as "Recall is being initiated due to the part being mislabeled (Part Number 241.267 was mislabeled with Part Number 241.276)". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2278-2013
Classification: Class II
Status: Terminated
Initiated: 2013-03-08
Posted: 2013-09-25
Terminated: 2015-05-21
Recalling firm: Synthes GmbH
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.
Product code: KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Reason for recall: Recall is being initiated due to the part being mislabeled (Part Number 241.267 was mislabeled with Part Number 241.276).
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: 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.
Quantity in commerce: 2
Distribution: Nationwide Distribution including CA,and VA. .
Product codes and lots: Part Number 241.267, lot number 8037923

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2278-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2278-2013	Class II	Terminated	Voluntary: Firm initiated	2013-10-02	2013-09-25

Product code KTT

K033995Class II3.5 Mm Lcp Distal Humerus SystemSynthes (Usa) / cleared 2004-03-01

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)