The Recall Desk
HighFDA (Devices)·Z-2585-2016·Announced 2016-08-24

Synthes Recalls Titanium Single Vector Distractor Proximal Foot Plates

Synthes is voluntarily recalling Titanium Single Vector Distractor Proximal Foot Plates because the 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 injury has not yet been reported, fitting the criteria for a High severity score.

Plain-English summary

Synthes (USA) Products LLC is voluntarily recalling 274 units of the Titanium Single Vector Distractor Proximal Foot/Right (Catalog ID 487.974). The recall is initiated due to a possibility that the fastener on the Titanium Single Vector Distractor Body may become prematurely separated from the Proximal Foot Plate.

The affected 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 recall includes units with Part # 487.974 and Lot# A4JY041, with manufacturing dates ranging from June 11, 1999, to December 21, 2015, and expiration dates from July 20, 2019, to December 21, 2035.

The affected units were distributed nationwide in the United States to the states of AZ, CA, CO, DC, FL, IL, MA, MI, NJ, NY, PA, TX, UT, WI, and WV, as well as to Australia, Canada, and Switzerland. Healthcare providers should contact Synthes for further instructions regarding the recall.

The recalled product

Product
TI Single Vector Distractor Proximal Foot/Right; Catalog ID 487.974 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 defici
Manufacturer
Synthes (USA) Products LLC
Category
Medical Device — Orthopedic Implant
Hazard
Affected units
274

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 # 487.974
  • Lot# A4JY041
  • 3949739
  • 4038565
  • 4044599
  • 4091233
  • 4600267
  • 4744818
  • 4745317
  • 4873173
  • 4873174
  • 5202231
  • 5202232
  • 5202233
  • 5202234
  • 5298113
  • 5304974
  • 5354033
  • 5469087
  • 5820678

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 · premature separation

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