Synthes Synapse SD Drill Guide Recalled for Incorrect Etching
Synthes USA HQ, Inc. is recalling two Synapse SD Drill Guides with incorrect etching. The error could lead to the use of the wrong drill size 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 defect that could lead to improper surgical procedure (wrong drill size), representing a risk of harm where injury has not yet been reported, consistent with the 'High' severity criteria.
Plain-English summary
Synthes USA HQ, Inc. is recalling two units of the Synthes Synapse SD Drill Guide, Part Number SD389.477, Lot Number 6913900. The recall was initiated after a field complaint reported that the drill guide was etched incorrectly, displaying a 12mm etch instead of the correct 18mm drill guide marking.
The affected devices are indicated for use with Hooks, Plate/Rods, Rods, and Screws to promote fusion of the cervical spine and occipitocervical junction. The incorrect etching presents a risk that a surgeon might use an improperly sized drill, which could compromise the safety and efficacy of the spinal fusion procedure.
The distribution was limited to Pennsylvania. The firm identified this as a field action and retrospectively reported it to the FDA. Healthcare facilities and distributors should stop using the affected units and contact Synthes USA HQ, Inc. for instructions on return or replacement.
The recalled product
- Product
- Synthes Synapse SD Drill Guide, Part Number SD389.477, Lot Number 6913900 Indicated for Hooks, Plate/Rods, Rods and Screws when intended to promote fusion of the cervical spine fusion of the cervical spine and occipitocervical junction (occiput-T3), the plate/rod, rod, hook…
- Manufacturer
- Synthes USA HQ, Inc.
- Affected units
- 2
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 (2)
- Part Number SD389.477
- Lot Number 6913900
Distribution
Distributed in 1 state:
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