CLASS II Device recall · Reported 27 Aug 2014 · FDA Enforcement Report
TI Cannulated Screw Instrument and Implant Set recalled by Synthes
Synthes is recalling TI Cannulated Screw Instrument and Implant Set, distributed in Michigan, Wisconsin. The recall was initiated on 30 Jun 2014 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2265-2014
- FDA event ID
- 68738
- Recalling firm
- Synthes, West Chester, PA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 30 Jun 2014
- FDA classified
- 18 Aug 2014
- Reported
- 27 Aug 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Heart & Vascular Devices
Timeline
| 30 Jun 2014 | Recall initiated by company | |
| 18 Aug 2014 | Classified by FDA | +49 days |
| 27 Aug 2014 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
Synthes 3.0 MM TI Cannulated Screw Instrument and Implant Set
Where it was distributed
Distributed in the states of WI and MI.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
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.
Where was it sold?
Distributed in the states of WI and MI.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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