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Recall Observatory FDA recall evidence

Device product

SPEED 9X10X10mm Continuous Compression Implant, Product No. SE-0910

Z-0100-2023

September 27, 2022

Class II

Product summary

Firm
Synthes (USA) Products LLC
Event
Event 90918
Status
Ongoing
Classification
Class II
Quantity
96
Official record key
device-enforcement:Z-0100-2023

Official wording

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 information: UDI-DI (GTIN): 00810633020111 Lot/Expiry MSE210240 7/1/2027

Distribution pattern: US Nationwide distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.