The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1326-2016·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, which may affect 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 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 defect involves a structural deviation (undersized thread height) in a medical device used for craniofacial surgery, which presents a risk of harm even though no specific injuries are reported in the source text.

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 9960359, 9962300, and 9967875. The FDA has classified this as a Class II recall.

The reason for the recall is that the thread height of the affected screws is undersized. The cross-section of the affected area is less than that of conforming screws, resulting in a deviation from the specified thread dimensions. This defect could potentially impact the structural integrity of the device during use.

A total of 500 units were distributed in the United States and 35 units were distributed outside the US. The affected products 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 that have received these specific lots should stop using them and contact Synthes (USA) Products LLC for instructions on return or replacement.

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 (7)

  • Titanium Low Profile Neuro Screw
  • Self-Drilling
  • 3mm
  • part number # 400.833
  • Lot numbers: 9960359
  • 9962300
  • 9967875

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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