Synthes USA HQ, Inc.: Medical Device Recall in 2013 - (Recall #: Z-0941-2013)

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:

Large Combination Clamp/Large External Fixation System, Part Number 390.005 Product Usage: Synthes Large External Fixation is intended for use to provide treatment for long bone and pelvic fractures that require external fixation.

Product Classification:

Class II

Date Initiated: January 11, 2013

Date Posted: March 20, 2013

Recall Number: Z-0941-2013

Event ID: 64159

Reason for Recall:

The L1 hex nuts, used to tighten the Large Combination Clamp, were oversized and the 11 mm sockets and wrenches will not fit on the hex nuts.

Status: Terminated

Product Quantity: 136

Code Information:

Lot Numbers 6602070, 6582333, 6581191, and 6581193

Distribution Pattern:

USA Nationwide Distribution including the states of AL, AR, AK, CA, FL, ID, KS, LA, MD, MA, MO, NJ, NY, OH, PA, TN, TX, and VA.

Voluntary or Mandated:

Voluntary: Firm initiated