Synthes (USA) Products LLC: Medical Device Recall in 2013 - (Recall #: Z-0404-2014)

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 14.5 mm Outer Protection Sleeve for Suprapatellar Synthes 14.5 mm Outer Protection Sleeve for Suprapatellar is used as part of the Synthes Tibial Nail System EX to stabilize fractures of the proximal and distal tibia and the tibia shaft, open and closed tibia shaft fractures, certain pre- and post- isthmic fractures, and tibial malunions and non-unions.

Product Classification:

Class II

Date Initiated: October 14, 2013

Date Posted: December 4, 2013

Recall Number: Z-0404-2014

Event ID: 66581

Reason for Recall:

Complaints were received reporting that a product packaged as a 14.5 mm Outer Protection Sleeve for Suprapatellar contained a 12.0 mm Outer Protection Sleeve for Suprapatellar.

Status: Terminated

Product Quantity: 55

Code Information:

part no. 03010.438S, lot 706802

Distribution Pattern:

Nationwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated