Synthes, Inc.: Medical Device Recall in 2015 - (Recall #: Z-2051-2015)

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:

TITANIUM END CAP WITH T40 STARDRIVE RECESS, 0MM EXTENSION FOR TITANIUM TIBIAL NAILS-EX; Synthes Tibial Nail System EX is intended to stabilize fractures of the proximal and distal tibia and the tibial shaft; open and closed tibial shaft fractures; certain pre-and post-isthmic fractures; and tibial malunions and non-unions.

Product Classification:

Class II

Date Initiated: June 3, 2015

Date Posted: July 15, 2015

Recall Number: Z-2051-2015

Event ID: 71440

Reason for Recall:

A specific part and lot number was packaged and shipped prior to the completion of a required internal inspection.

Status: Terminated

Product Quantity: 3

Code Information:

Part # 04.004.000, lot # 7950994

Distribution Pattern:

US Distribution to states of: MO and SC.

Voluntary or Mandated:

Voluntary: Firm initiated