Synthes Spine Vectra Adjustable Drill Stop Recalled for Slip Risk
Synthes USA is recalling 48 units of the Spine Vectra Adjustable Drill Stop because the device may slip on the drill bit, posing a risk of adverse events during surgery.
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 mechanical defect that poses a risk of harm (adverse event) during surgery, but the source text explicitly states that the reported incidence is low and does not cite specific injuries or fatalities, fitting the 'High' criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Synthes USA HQ, Inc. is recalling 48 units of the Synthes(R) Spine Vectra, Vectra-T and Vectra-One Anterior Cervical Plating for Spinal Fusion, Adjustable Drill Stop, Part Number 03.613.012. The affected lots are 5456424, 5494147, 5557938, and 5557939. These devices are intended for anterior plate and screw fixation of the cervical spine (C2-C7).
The recall is being conducted 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 affected products were distributed nationwide, including Puerto Rico and all 50 states. Healthcare facilities and distributors should stop using the affected units and contact Synthes USA HQ, Inc. for further instructions on return or replacement.
The recalled product
- Product
- Synthes(R) Spine Vectra, Vectra-T and Vectra-One Anterior Cervical Plating for Spinal Fusion, Adjustable Drill Stop, Part Number 03.613.012. Synthes Vectra System, Synthes Vectra-One System and Synthes Vectra-T System is intended for anterior plate and screw fixation of the…
- Manufacturer
- Synthes USA HQ, Inc.
- Affected units
- 48
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 (5)
- Adjustable Drill Stop
- Part Number 03.613.012 - Lots 5456424
- 5494147
- 5557938
- and 5557939
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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