FDAFDA · Food and drugs·Recall number Z-2265-2014
Synthes 3.0 MM TI Cannulated Screw Instrument and Implant Set
Published August 27, 2014 · Recall initiated: June 30, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Synthes, Inc.
- Distributor
- Distributed in the states of WI and MI.
- Lot
- 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.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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