The Recall Desk
ModerateFDA (Devices)·Z-0867-2017·Announced 2016-12-28

Synthes VA Implant Rack Recalled for Incorrect Assembly

Synthes (USA) Products LLC is recalling 31 units of the VA Implant Rack for the Compact Distal Radius System because incorrect assembly could cause screws to touch the surface beneath the rack.

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, and the source text describes a mechanical assembly defect without reporting any injuries, illnesses, or fatalities, fitting the criteria for a moderate severity score.

Plain-English summary

Synthes (USA) Products LLC is recalling 31 units of the Synthes VA Implant Rack for the Compact Distal Radius System (Tray/Surgical/Instrument). The recall involves units with Catalog ID 60.119.012 and Lot Number FL00528, which were distributed nationwide.

The recall was initiated because the screw rack plate was assembled incorrectly. This defect could cause the screws in the screw rack to sit low and touch the surface beneath the screw rack.

Healthcare providers and facilities that have received these specific units should stop using them and contact the recalling firm for instructions on return or disposal.

The recalled product

Product
Synthes VA Implant Rack for the Compact Distal Radius System Tray/Surgical/Instrument
Manufacturer
Synthes (USA) Products LLC
Category
Medical Device — Surgical Instrument
Hazard
Affected units
31

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 (2)

  • Catalog ID (part # 60.119.012)
  • Lot Number FL00528

Distribution

Distributed nationwide across the United States.

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