Synthes USA HQ, Inc.: Medical Device Recall in 2013 - (Recall #: Z-2278-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: March 8, 2013

Date Posted: October 2, 2013

Recall Number: Z-2278-2013

Event ID: 65009

Reason for Recall:

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

Status: Terminated

Product Quantity: 2

Code Information:

Part Number 241.267, lot number 8037923

Distribution Pattern:

Nationwide Distribution including CA,and VA. .

Voluntary or Mandated:

Voluntary: Firm initiated