Synthes (USA) Products LLC: Medical Device Recall in 2015 - (Recall #: Z-2425-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

Synthes Tibial Nail Wrap Holds 11 Nails and Synthes Intramedullary Nail Wrap Holds 10 Nails; the Nail Wrap is intended to be used as a protective sheath specifically for Universal Femoral Nails, Universal Tibial Nails, Unreamed Tibial Nail, and the Stainless Steel Tibial Nail during steam sterilization by the hospital.

Product Classification:

Class II

Date Initiated: July 1, 2015

Date Posted: August 26, 2015

Recall Number: Z-2425-2015

Event ID: 71713

Reason for Recall:

The wrap is for single use for nail sterilization but does not have sufficient testing for the device to be considered a multi-use item.

Status: Terminated

Product Quantity: 1487

Code Information:

all lots of part numbers: 900.50, 900.51

Distribution Pattern:

Worldwide Distribution - US Distribution including Puerto Rico and to the countries of : Canada, Switzerland and New Zealand.

Voluntary or Mandated:

Voluntary: Firm initiated