SPEEDSHIFT20x20x20 Offset 10mm Implant Drill Kit recall
SPEEDSHIFT20x20x20 Offset 10mm Implant Drill Kit, Product No. SE-2020-10. Used with DePuy Synthes SPEEDSHIFT Continuous Compression Staple Implants…
Why was SPEEDSHIFT20x20x20 Offset 10mm Implant Drill Kit recalled?
The subject products are being recalled because they contain the incorrect size drill guide and will not prepare the bone correctly for the size of the implant included in the sterile kit. If the incorrect drill guide is used, there is potential for bone damage due to incorrectly placed drill holes for the implant included in the kit.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA 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?
UDI-DI (GTIN): 00810633020494 Lot MSE210237 Expiry 11/1/2026
- Product
- SPEEDSHIFT20x20x20 Offset 10mm Implant Drill Kit, Product No. SE-2020-10. Used with DePuy Synthes SPEEDSHIFT Continuous Compression Staple Implants…
- Recalling firm
- Synthes (USA) Products LLC
- Quantity
- 81
- Distribution
- US Nationwide distribution.
- Recall date
- October 26, 2022
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)