Product Safety Recalls

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BioPro, Inc. Recall 89605

Description: Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC MD, Part ID 16814

BioPro, Inc. Recall 89605 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0683-2022
Event ID89605
Event DescriptionTitanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC MD, Part ID 16814
Product TypeDevices
DistributionUS Nationwide distribution in the states of CT, KY, NM, PA, TN, and SD.
Recall ReasonThere 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.
Device Classification20220309
Device Code InfoLot Number: 125423, 128356; UDI: 00810012480093
Center Classification Date20220228
Recall Initiation Date20220201
Recalling FirmBioPro, Inc.
Initial Notification Letter
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