Synthes Pull Reduction Device Recalled for Potential Intraoperative Breakage
Synthes, Inc. is recalling Pull Reduction Devices for 4.3mm Percutaneous Drill Guides because incorrect hardness specifications may cause the devices to break 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 is classified as FDA Class II, and the hazard involves a risk of harm (intraoperative breakage) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Synthes, Inc. is recalling certain lots of the Pull Reduction Device for 4.3mm Percutaneous Drill Guide. The device is a medical instrument used to pull or push bone fragments relative to a plate during orthopedic procedures, including minor varus-valgus adjustments and stabilization of plate bone orientation.
The recall is being conducted because certain affected parts and lots may have been manufactured to an incorrect hardness specification. This defect could result in the device breaking intraoperatively, or during the surgical procedure.
The recall involves 3,747 units in the United States and 19 units in foreign markets. The affected products were distributed nationwide in the US and internationally to Canada. The specific part number is 03.120.023, and the recall covers a specific list of lot numbers provided in the agency's official documentation.
The recalled product
- Product
- Pull Reduction Device For 4.3mm Percutaneous Drill Guide; The pull reduction device with quick coupling is placed through the guide sleeve and plate holes to pull or push bone fragments relative to the plate. This instrument can be used for: Minor Varus-valgus adjustments…
- Manufacturer
- Synthes, Inc.
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 (1)
- Part Number: 03.120.023
Distribution
Distributed nationwide across the United States.
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