FDA Enforcement
Class II
Ongoing
SPEEDSHIFT20x20x20 Offset 10mm Implant Drill Kit, Product No. SE-2020-10. Used with DePuy Synthes SPEEDSHIFT Continuous Compression Staple Implants for bone fixation and management of fracture and reconstructive surgery.
Recall: Z-0098-2023
·
Reported October 26, 2022
Enforcement
- Recall Number
- Z-0098-2023
- Event ID
- 90918
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Synthes (USA) Products LLC
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- October 26, 2022
- Initiation Date
- September 27, 2022
- Classification Date
- October 18, 2022
- Address
- 1301 Goshen Pkwy, N/A, West Chester, PA, 19380-5986, United States
Description
SPEEDSHIFT20x20x20 Offset 10mm Implant Drill Kit, Product No. SE-2020-10. Used with DePuy Synthes SPEEDSHIFT Continuous Compression Staple Implants for bone fixation and management of fracture and reconstructive surgery.
Reason
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.
Code Info
UDI-DI (GTIN): 00810633020494 Lot MSE210237 Expiry 11/1/2026
Distribution
US Nationwide distribution.
Quantity
81