Synthes USA HQ, Inc.: Medical Device Recall in 2013 - (Recall #: Z-1062-2013)

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:

Flexible Grip which is part of the Synthes Universal Nail System. Indicated for the conventional (non-locking) technique of treating stable diaphyseal fractures.

Product Classification:

Class II

Date Initiated: January 11, 2013

Date Posted: April 17, 2013

Recall Number: Z-1062-2013

Event ID: 64200

Reason for Recall:

Synthes is initiating a voluntary recall of the Flexible Grip (Part number 355.28) which is part of the Universal Nail System, due to the potential lack of the ability to thoroughly clean the instrument.

Status: Terminated

Product Quantity: 328

Code Information:

Part number 355.28, all lot numbers

Distribution Pattern:

Nationwide Distribution including the states of AZ, CA, CO, FL, IA, ID, GA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, NC, NH, NJ, NV, NY, OH, PA, RI, TN, TX, UT, VT, WA, WI, and WV.

Voluntary or Mandated:

Voluntary: Firm initiated