Synthes USA HQ, Inc.: Medical Device Recall in 2012 - (Recall #: Z-2059-2012)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

Product Description:

4.5mm TI Multiloc Screw Length 38MM-Sterile Expiration: 04/29/2012 REF 04.019.038S Manufactured or Distributed by Synthes (USA) 1101 Synthes Avenue, Monument CO 80132 4.5MM TI Multiloc Screw Length 38MM-Sterile Ref 04.019,038S. The Multiloc Screw 4.5 is used with a Multiloc PHN for treatment of proximal humerus fractures and is intended to be inserted through the Multiloc PHN until it engages the subchondral bone below the relative distal cortex (cortex closest to the humeral head, below the articular surface).

Product Classification:

Class II

Date Initiated: May 22, 2012

Date Posted: August 1, 2012

Recall Number: Z-2059-2012

Event ID: 62307

Reason for Recall:

Two lots of 4.5mm multi-loc screws were recalled due to incorrect labeling of screw size.

Status: Terminated

Product Quantity: 20

Code Information:

Lot #2724103 Expiration 4/29/2012 REF 04.019.038S

Distribution Pattern:

Nationwide Distribution-including the states of AZ, CA, FL, GA, IL, LA, MD, MN, NJ, NY, OH, PA, TN, TX, and VA.

Voluntary or Mandated:

Voluntary: Firm initiated