SPEED 9X10X10mm Continuous Compression Implant, Product No. SE-0910
Reported: October 26, 2022 Initiated: September 27, 2022 #Z-0100-2023
Product Description
SPEED 9X10X10mm Continuous Compression Implant, Product No. SE-0910
Reason for Recall
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.
Details
- Recalling Firm
- Synthes (USA) Products LLC
- Units Affected
- 96
- Distribution
- US Nationwide distribution.
- Location
- West Chester, PA
Frequently Asked Questions
What product was recalled? ▼
SPEED 9X10X10mm Continuous Compression Implant, Product No. SE-0910. Recalled by Synthes (USA) Products LLC. Units affected: 96.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 26, 2022. Severity: Moderate. Recall number: Z-0100-2023.
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