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Recall Observatory FDA recall evidence

Device product

Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC ML, Part ID 16815

Z-0684-2022

February 01, 2022

Class II

Product summary

Firm
BioPro, Inc.
Event
Event 89605
Status
Terminated
Classification
Class II
Quantity
Unavailable
Official record key
device-enforcement:Z-0684-2022

Official wording

Reason: There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU (IFU BP102303 rev 05) and patient implant cards (22266 rev 00) which indicates that the BioPro MPJ Implant has been tested for safety and compatibility in the MR Environment and is MR Conditional. MR Testing has not been conducted on the titanium version of the MPJ.

Code information: Lot Number: 124738, 127602; UDI: 00810012480109

Distribution pattern: US Nationwide distribution in the states of CT, KY, NM, PA, TN, and SD.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU (IFU BP102303 rev 05) and patient implant cards (22266 rev 00) which indicates that the BioPro MPJ Implant has been tested for safety and compatibility in the MR Environment and is MR Conditional. MR Testing has not been conducted on the titanium version of the MPJ.