Synthes, Inc.: Medical Device Recall in 2014 - (Recall #: Z-2265-2014)

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 3.0 MM TI Cannulated Screw Instrument and Implant Set

Product Classification:

Class II

Date Initiated: June 30, 2014

Date Posted: August 27, 2014

Recall Number: Z-2265-2014

Event ID: 68738

Reason for Recall:

A screw set was returned from the field for destruction after being exposed to flood water, which was erroneously reprocessed and returned to the field. Initial investigative testing indicated the components within the set may be cytotoxic.

Status: Terminated

Product Quantity: 4

Code Information:

Part Number: 145.17E Lot Number: EV01609, individual part numbers contained within 145.17E: 304.49 309.501 310.221 310.804 311.43 312.151 312.153 313.969 314.463 314.464 314.465 319.291 319.292 319.702 319.97 398.408 398.409 402.608-402.640 402.714-402.740 419.89 419.972 292.622, and 292.623.

Distribution Pattern:

Distributed in the states of WI and MI.

Voluntary or Mandated:

Voluntary: Firm initiated