The Recall Desk
ModerateFDA (Devices)·Z-0656-2017·Announced 2016-11-30

Synthes Flexible Shaft Orthopedic Surgical Instrument Recalled for Non-Conforming Material

Synthes (USA) Products LLC is recalling 198 units of Flexible Shaft orthopedic surgical instruments because non-conforming material was used in their manufacture.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, which typically involves a situation where use of the product could cause temporary or medically reversible health consequences. The source text cites 'non-conforming material' without reporting specific injuries or illnesses, aligning with a moderate severity assessment for a medical device.

Plain-English summary

Synthes (USA) Products LLC is recalling 198 units of Synthes Flexible Shaft, an orthopedic manual surgical instrument. These flexible shafts are intended for use as an optional reaming step in intramedullary nailing systems. The recall is being conducted because non-conforming material was used in the production of the devices.

The affected products were distributed nationwide in the United States. The recall covers specific part numbers and lot numbers, including Part Number 352.040 (Lot # 9947895, L084498) and Part Number 352.044 (Lot # 9916503, 9916508, L000158, L000160, L000573, L000603, L000604, L000605, L000607, L000632, L082974).

Healthcare providers and facilities should check their inventory for these specific part and lot numbers. If the recalled products are found, they should be removed from use and returned to the manufacturer or the appropriate FDA representative as directed.

The recalled product

Product
Synthes Flexible Shaft, Orthopedic manual surgical instrument The Flexible shafts are intended for use as an optional reaming step in intramedullary nailing systems.
Manufacturer
Synthes (USA) Products LLC
Category
Medical Device — Orthopedic Instrument
Hazard
Affected units
198

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (10)

  • Part Number 352.040 - Lot # 9947895
  • L084498 Part Number 352.044 - Lot # 9916503 9916508
  • L000158
  • L000160
  • L000573
  • L000603
  • L000604
  • L000605
  • L000607
  • L000632 L082974

Distribution

Distributed nationwide across the United States.

Related recalls

Same manufacturer · Synthes (USA) Products LLC

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