Drill Template and the Saw Guide for the Ulna Osteotomy recall
Drill Template and the Saw Guide for the Ulna Osteotomy System. Intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions…
Why was Drill Template and the Saw Guide for the Ulna Osteotomy recalled?
The Drill Template and the Saw Guide for the Ulna Osteotomy System 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 fixation of the Drill Template.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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.
- Product
- Drill Template and the Saw Guide for the Ulna Osteotomy System. Intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions…
- Recalling firm
- Synthes, Inc.
- Quantity
- 343
- Distribution
- Nationwide Distribution-including the states of AR, AK, VA, IN, PA, OH, CT, TX, MI, WI, NC, CO, IL, and MA.
- Recall date
- April 2, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)