Synthes Orthopedic Implant Drill Kit Recall: Incorrect Drill Guide Size
Synthes (USA) Products LLC is recalling 81 SPEEDSHIFT20x20x20 Offset 10mm Implant Drill Kits nationwide due to incorrect drill guide sizing. The defect could result in bone damage and incorrectly placed drill holes during orthopedic surgery.
What this means for you
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: This is an FDA Class II surgical implant device with a manufacturing defect that creates direct potential for serious bone damage and surgical complications. No illnesses or injuries have been reported, but the hazard is certain if the defective device is used.
Plain-English summary
The SPEEDSHIFT20x20x20 Offset 10mm Implant Drill Kit (Product No. SE-2020-10), manufactured by Synthes (USA) Products LLC, is being recalled. The kit contains an incorrect size drill guide that 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. This product is used for bone fixation and management of fracture and reconstructive surgery procedures.
The recalled lot (MSE210237, UDI-DI: 00810633020494) comprised 81 units distributed nationwide throughout the United States, with an expiration date of 11/1/2026.
The recalled product
- Product
- 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.
- Manufacturer
- Synthes (USA) Products LLC
- Hazard
- bone-damage
- surgical-defect
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)
- UDI-DI (GTIN): 00810633020494 Lot MSE210237 Expiry 11/1/2026
Distribution
Distributed nationwide across the United States.
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