CLASS II Device recall · Reported 30 Nov 2016 · FDA Enforcement Report
Synthes Flexible Shaft, Orthopedic manual surgical recalled
Synthes (USA) Products is recalling Synthes Flexible Shaft, Orthopedic manual surgical instrument The Flexible shafts are, distributed nationwide in the US. The recall was initiated on 31 Oct 2016 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-0656-2017
- FDA event ID
- 75580
- Recalling firm
- Synthes (USA) Products, West Chester, PA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 31 Oct 2016
- FDA classified
- 23 Nov 2016
- Reported
- 30 Nov 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Hip & Knee Implants
Timeline
| 31 Oct 2016 | Recall initiated by company | |
| 23 Nov 2016 | Classified by FDA | +23 days |
| 30 Nov 2016 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Non-conforming material used.
Product as listed by the FDA
Synthes Flexible Shaft, Orthopedic manual surgical instrument The Flexible shafts are intended for use as an optional reaming step in intramedullary nailing systems.
Where it was distributed
US Nationwide Distribution.
Questions about this recall
Why was it recalled?
Non-conforming material used.
Which lots are affected?
Part Number 352.040 - Lot # 9947895, L084498 Part Number 352.044 - Lot # 9916503 9916508,L000158,L000160,L000573,L000603,L000604,L000605,L000607,L000632 L082974
Where was it sold?
US Nationwide Distribution.
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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| Device | CLASS II | U2 Total Knee System Femoral offset bushing recalled | United Orthopedic | Device Malfunction | Nationwide |