Synthes, Inc.: Medical Device Recall in 2014 - (Recall #: Z-1057-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

Synthes Driving Cap/Threaded Both parts are intended for use in the Tibia system, LFN and RAFN systems. Their function is to insert a nail. The Synthes Driving Cap/Threaded is threaded into the insertion handle and secured with a wrench. If desired, the nail can then be inserted using light hammer blows.

Product Classification:

Class II

Date Initiated: January 7, 2014

Date Posted: February 26, 2014

Recall Number: Z-1057-2014

Event ID: 67261

Reason for Recall:

The Synthes Driving Cap/Threaded can bind in the IM Nail Radiolucent Insertion Handles when assembled becoming difficult to separate.

Status: Terminated

Product Quantity: 143

Code Information:

Part No. 03.010.523, Lot Nos. 8279162 & 8429004

Distribution Pattern:

USA (nationwide) Distribution.

Voluntary or Mandated:

Voluntary: Firm initiated