The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2583-2016·Announced 2016-08-24

Synthes Recalls Titanium Single Vector Distractor Bodies Due to Fastener Separation Risk

Synthes (USA) Products LLC is voluntarily recalling 413 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 defect in a medical device where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.

Plain-English summary

Synthes (USA) Products LLC is voluntarily recalling 413 units of the Titanium Single Vector Distractor Body with Right Foot/30mm (Catalog ID 487.964). The recall is initiated due to a possibility that the fastener on the device 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 with Part #487.964 and Lot # A4JV280, as well as specific serial numbers listed in the agency record. Manufacturing dates range from May 17, 1999, to September 4, 2014, with expiration dates ranging from March 22, 2020, to September 4, 2034.

The affected products 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 on how to proceed with the recall.

The recalled product

Product
TI Single Vector Distractor Body with Right Foot/30mm; Catalog ID 487.964 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 / Maxillofacial
Hazard
Affected units
413

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 #487.964
  • Lot # A4JV280
  • 4038562
  • 4091232
  • 4095219
  • 4454474
  • 4485940
  • 4538241
  • 5021030
  • 5041163
  • 5051836
  • 5140379
  • 5175699
  • 5292906
  • 5321397
  • 5321398
  • 5321399
  • 5332085
  • 5391292
  • 5505143

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

See all →

Same hazard · structural defect

See all →

Similar recalls