The Recall Desk
HighFDA (Devices)·Z-2586-2016·Announced 2016-08-24

Synthes Titanium Single Vector Distractor Recalled for Fastener Separation Risk

Synthes is recalling Titanium Single Vector Distractor Proximal Foot/Left devices because a fastener may separate prematurely from the plate.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a structural defect in a medical device where a component may separate, posing a risk of harm, but the source text does not report any specific injuries or illnesses.

Plain-English summary

Synthes (USA) Products LLC is voluntarily recalling 599 units of the Titanium Single Vector Distractor Proximal Foot/Left (Catalog ID 487.975). The recall is initiated due to the possibility that the fastener on the Titanium Single Vector Distractor Body may become prematurely separated from the Proximal Foot Plate.

These medical devices are intended for mandibular bone lengthening where gradual bone distraction is required, including conditions such as congenital mandibular deficiencies or post-traumatic defects. The affected units were distributed nationwide in the United States to states including AZ, CA, CO, DC, FL, IL, MA, MI, NJ, NY, PA, TX, UT, WI, and WV, as well as to Australia, Canada, and Switzerland.

The recall covers units with Part #487.975 and Lot# A4JV281, manufactured between May 14, 1999, and April 22, 2015. Healthcare providers and patients should contact Synthes (USA) Products LLC for further instructions regarding the return or replacement of these devices.

The recalled product

Product
TI Single Vector Distractor Proximal Foot/Left; Catalog ID 487.975 The Titanium Single Vector Distractor and Proximal Foot Plates are intended for mandibular bone lengthening where gradual bone distraction is required, including conditions such as congenital mandibular deficie
Manufacturer
Synthes (USA) Products LLC
Category
Medical Device — Orthopedic
Hazard
Affected units
599

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 (20)

  • Part #487.975
  • Lot# A4JV281
  • 3959732
  • 3959733
  • 4038566
  • 4044600
  • 4095085
  • 4418691
  • 4479352
  • 4597089
  • 4767010
  • 4851967
  • 4851968
  • 5277361
  • 5346057
  • 5419963
  • 5433149
  • 5445352
  • 5445632
  • 5445638

Distribution

Distributed nationwide across the United States.

The notice also names 15 states specifically:

Part of a larger recall action

This product is one of 6 recalled by Synthes (USA) Products LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 6 products in this recall →

Related recalls

Same manufacturer · Synthes (USA) Products LLC

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Same hazard · structural defect

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