Synthes USA HQ, Inc.: Medical Device Recall in 2013 - (Recall #: Z-2058-2013)

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 Trauma Nail System. The devices are indication for bone fixation.

Product Classification:

Class II

Date Initiated: November 2, 2012

Date Posted: September 4, 2013

Recall Number: Z-2058-2013

Event ID: 65631

Reason for Recall:

Recall was initiated due to the possibility that the outer pouch was compromised. The product is packaged in two pouches; a sterile, internal pouch within an external pouch. It is the outer, external pouch that may be compromised.

Status: Terminated

Product Quantity: 1,011,783

Code Information:

Trauma Ex Nails, all lot numbers up to and including lot # 7072305 and Trochanteric Fixation Nails, all lot numbers up to and including lot # 7060897

Distribution Pattern:

Nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated