Synthes Ulna Osteotomy System Drill Template and Saw Guide Recall
Synthes, Inc. is recalling 343 Drill Templates and Saw Guides for the Ulna Osteotomy System due to potential mechanical failure of connecting screws or K-wires.
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 during surgery, but the source text does not report any specific injuries or illnesses, fitting the criteria for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Synthes, Inc. is recalling 343 units of the Drill Template and Saw Guide for the Ulna Osteotomy System. These medical devices are intended for the fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragments, including osteopenic bone in the ulna.
The recall is issued because the devices may exhibit jamming, bending, or breaking of the screw connecting the Saw Guide to the Drill Template, or jamming, bending, or breaking of the K-wire during the fixation of the Drill Template. The affected units are identified by Part Nos. 03.111.900 through 03.111.905 and specific lot numbers including 779372, 2638601, 7769386, 2638603, 7836420, 7772531, 2638604, 7836422, 7772538, 2638605, 7836423, 7915554, 7772543, 7772542, 7872775, 8400287, 7772554, 7772555, and 8229040.
The affected products were distributed nationwide, including in the states of AR, AK, VA, IN, PA, OH, CT, TX, MI, WI, NC, CO, IL, and MA. Healthcare providers and facilities should stop using these devices and contact Synthes, Inc. for further instructions.
The recalled product
- Product
- Drill Template and the Saw Guide for the Ulna Osteotomy System. Intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragments, including osteopenic bone in the ulna.
- Manufacturer
- Synthes, Inc.
- Affected units
- 343
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 (20)
- Part Nos. 03.111.900 through 03.111.905
- with Lot Nos. 779372
- 2638601
- 7769386
- 2638603
- 7836420
- 7772531
- 2638604
- 7836422
- 7772538
- 2638605
- 7836423
- 7915554
- 7772543
- 7772542
- 7872775
- 8400287
- 7772554
- 7772555
- and 8229040.
Distribution
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