Synthes 3.0 MM TI Cannulated Screw Instrument and Implant Set
This recall has been terminated (originally issued August 19, 2014).
- Company
- Synthes, Inc.
- Recall Initiated
- June 30, 2014
- Posted
- August 19, 2014
- Terminated
- December 18, 2015
- Recall Number
- Z-2265-2014
- Quantity
- 4
- Firm Location
- West Chester, PA
- Official Source
- View on FDA website ↗
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.
Distribution
Distributed in the states of WI and MI.
Lot / Code Info
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.
Root Cause
Employee error
Action Taken
An Urgent Field Safety Notification, dated July 21, 2014, was sent to surgeons explaining the product, problem, and action to be taken with regard to routine post-operative follow-up on patients exposed to the affected product. Questions or concerns should be directed to Leonie Rynn at 610-719-5408 or lrynn1@its.jnj.com.