The Recall Desk
Agency classClass IIOur severity:SevereFDA (Devices)·Z-1327-2016·Announced 2016-04-13

Synthes Recalls Titanium Low Profile Neuro Screws Due to Thread Defect

Synthes (USA) Products LLC is recalling specific lots of Titanium Low Profile Neuro Screws because the thread height is undersized, potentially compromising the device's structural integrity.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II and involves a structural defect (undersized thread height) in a medical device used for craniofacial surgery, which meets the rubric criteria for a Severe rating due to the potential for significant injury.

Plain-English summary

Synthes (USA) Products LLC is recalling specific lots of Titanium Low Profile Neuro Screws, Self Drilling, 3mm. The recall involves part numbers 400.833 and 400.833E, specifically lot numbers 9958565, 9951621, 9952976, 9955377, 9962314, 9968868, and 9969645. These devices are intended for use in craniofacial surgery, reconstructive procedures, and selective trauma of the midface and craniofacial skeleton.

The recall was initiated because the screws are out of specification at the thread. The thread height of the affected screws is undersized, meaning the cross-section of the affected area is less than that of conforming screws. This defect may affect the structural integrity of the device during use.

A total of 150 units were distributed in the United States and 1,439 units were distributed outside the US. The affected units were distributed nationwide in the US, including in Massachusetts, Virginia, Tennessee, Georgia, Washington, Iowa, New Jersey, Pennsylvania, New York, Colorado, Connecticut, and Vermont, as well as in Canada and Switzerland. Healthcare providers and facilities should check their inventory for these specific lot numbers and stop using the affected devices.

The recalled product

Product
Titanium Low Profile Neuro Screw, Self Drilling, 3mm, part numbers: 400.833, 400.833E Product Usage: The Low Profile Neuro Plating System is intended for use in selective trauma of the midface and craniofacial skeleton; craniofacial surgery; reconstructive procedures; and…
Manufacturer
Synthes (USA) Products LLC
Category
Medical Device — Orthopedic / Craniofacial
Hazard

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 (11)

  • Titanium Low Profile Neuro Screw
  • Self-Drilling
  • 3mm
  • part number # 400.833E
  • Lot numbers: 9958565
  • 9951621
  • 9952976
  • 9955377
  • 9962314
  • 9968868
  • 9969645

Distribution

Distributed nationwide across the United States.

The notice also names 12 states specifically:

Part of a larger recall action

This product is one of 2 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 2 products in this recall →

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