Stryker Spine Recalls Aviator Drill Bits Due to Over-Drilling Risk
Stryker Spine is recalling Aviator Drill Bits because they are 10 mm longer than Reflex Hybrid bits and not interchangeable, posing a risk of over-drilling.
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 involves a risk of harm (over-drilling) where injury has not yet been reported, meeting the criteria for a High severity score.
Plain-English summary
Stryker Spine is recalling Aviator Drill Bits (10 mm, 12 mm, 14 mm, and 16 mm) because they are 10 mm longer than Reflex Hybrid drill bits and are not interchangeable. This design difference could lead to over-drilling by as much as 10 mm during use.
The recalled drill bits are reusable instruments sterilized prior to use and are used in conjunction with an Aviator Drill Guide to provide a pathway for screw insertion. They are part of the Aviator Anterior Cervical Plating (ACP) System, which is intended for use as an aid in cervical spinal fusion and unilateral fixation.
The recall involves 6,154 units distributed nationwide. The affected catalog numbers are 48770610, 48770612, and 48770616, and all lots are included. The FDA has classified this as a Class II recall.
The recalled product
- Product
- Aviator Drill Bit (10 mm, 12 mm, 14 mm, 16 mm, Manufactured by: Stryker Spine SAS Z.1 Marticot -33610- Cestas France +33 (0) 5.57.97.06.30 http://www.stryker.com Distributed in the USA by Stryker Spine 2 Pearl Ct., Allendale NJ 07401-1677 USA +1-201-750-8000 Drill bits…
- Manufacturer
- Stryker Spine
- Hazard
- Affected units
- 6,154
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 (3)
- E207315 Catalog number 48770610
- 48770612
- 48770616 All lots
Distribution
Distributed nationwide across the United States.
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