The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2584-2016·Announced 2016-08-24

Synthes Titanium Single Vector Distractor Body Recalled for Fastener Separation

Synthes (USA) Products LLC is voluntarily recalling Titanium Single Vector Distractor Bodies because the fastener may separate prematurely from the Proximal Foot Plate.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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 is classified as FDA Class II, and the hazard involves a structural failure of a medical device used in bone lengthening. While no specific injuries are reported in the source text, the risk of harm from a detached fastener in a surgical implant justifies a High severity rating under the rubric for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Synthes (USA) Products LLC is voluntarily recalling 259 units of the Titanium Single Vector Distractor Body with Left Foot/30mm (Catalog ID 487.965). The recall is initiated due to a possibility that the fastener on the 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 covers units manufactured between May 14, 1999, and April 27, 2016, with expiration dates ranging from September 24, 2019, to April 27, 2036.

The devices 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 and patients should contact Synthes (USA) Products LLC for further instructions regarding the recall and potential replacement or repair of the affected devices.

The recalled product

Product
TI Single Vector Distractor Body with Left Foot/30mm; Catalog ID 487.965 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…
Manufacturer
Synthes (USA) Products LLC
Category
Medical Device — Orthopedic Implant
Hazard
Affected units
259

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 # 487.965
  • Lot # A4JV312
  • 3959731
  • 3988317
  • 4038563
  • 4091229
  • 4095071
  • 4375627
  • 4375628
  • 4375629
  • 4407383
  • 4420112
  • 4435710
  • 4664397
  • 4664398
  • 4746860
  • 5021031
  • 5143278
  • 5175697
  • 5282148

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 →

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