Synthes Spine Drill Bit Recalled for Potential Drill Stop Slippage
Synthes USA is recalling 63 units of 2.5mm drill bits for the Vectra Spine System due to a potential drill stop slippage hazard.
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 involves a medical device with a potential for adverse events (drill stop slippage) where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Synthes USA HQ, Inc. is recalling 63 units of the Synthes(R) Spine Vectra, Vectra-T and Vectra-One Anterior Cervical Plating for Spinal Fusion 2.5mm Drill Bit. The affected product is identified by Part Number 03.613.011 and includes Lots 5443576, 5522810, 5537042, and 5557902. The drill bit features a graduated 12mm to 26mm adjustable depth.
The recall was initiated because there is a potential for the drill stop to slip on the drill bit, which could result in an adverse event. The source text notes that the reported incidence of this issue is low. The product is intended for anterior plate and screw fixation of the cervical spine (C2-C7).
The affected units were distributed nationwide, including Puerto Rico and all 50 states. Healthcare facilities and distributors should stop using the affected drill bits and contact Synthes USA HQ, Inc. for further instructions.
The recalled product
- Product
- Synthes(R) Spine Vectra, Vectra-T and Vectra-One Anterior Cervical Plating for Spinal Fusion - 2.5mm Drill Bit, graduated 12mm - 26mm adjustable depth, Part Number 03.613.011. Synthes Vectra System, Synthes Vectra-One System and Synthes Vectra-T System is intended for…
- Manufacturer
- Synthes USA HQ, Inc.
- Affected units
- 63
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 (6)
- 2.5mm Drill Bit
- graduated 12mm - 26mm adjustable depth
- Part Number 03.613.011 - Lots 5443576
- 5522810
- 5537042
- 5557902
Distribution
Part of a larger recall action
This product is one of 2 recalled by Synthes USA HQ, Inc. 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.
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