Recall Z-2265-2014
Synthes, Inc. · initiated June 30, 2014
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Synthes 3.0 MM TI Cannulated Screw Instrument and Implant Set
Codes / lots: 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.
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.
FDA-determined 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.
Details
- Recall number
- Z-2265-2014
- Initiated
- June 30, 2014
- Posted by FDA
- August 19, 2014
- Terminated
- December 18, 2015
- Product code
- HWC – Screw, Fixation, Bone
- Quantity
- 4
- Distribution
- Distributed in the states of WI and MI.
- Recalling firm
- Synthes, Inc., West Chester, PA