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Titanium MPJ (Toe Implant) TOE JOINT TITANIUM PC MD, Part… recallZ-0687-2022 · BioPro, Inc. · initiated Feb 1, 2022

Terminated

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from BioPro, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Labeling design

What the company is doing

An URGENT: MEDICAL DEVICE RECALL notification letter was distributed to customers on 2/1/22. Actions to be taken by the Customer BioPro has fully reviewed all records pertaining to the product and implant cards. To date, no implant cards have been issued for titanium MPJ implants. However, your facility has implanted one MPJ Implant whose IFU improperly contained the MR Conditional Statement. The information pertaining to that order is below. Please take the following actions 1. If the incorrect IFU was retained, replace it with the updated IFU, which has been included for your reference. Please dispose of the incorrect IFU. 2. Provide the enclosed corrected patient implant card to your patient who received the implant. 3. Please sign and return the following page acknowledging receipt of this notification. Actions Taken by the Recalling Firm All impacted labeling has been updated by BioPro. We apologize for any inconvenience or issue this may cause. Please feel free to contact BioPro directly if you have any questions. Hours of operation are Monday Friday from 8:00-5:00 PM est. If you are aware of any issues that may have occurred related to this implant, please notify BioPro, Inc immediately. You may additionally contact the FDA directly via the MedWatch Adverse Event Reporting program. Submit reports to the FDA through the MedWatch program in one of the following ways: " Complete the MedWatch Online Reporting Form (https://www.accessdata.fda.gov/scripts/medwatch/) " Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Recall details

Recall number
Z-0687-2022
Status
Terminated
Initiated by the company
Feb 1, 2022
Recalling firm
BioPro, Inc.
Product code
KWD
FDA submissions
K041595
Distribution
US Nationwide distribution in the states of CT, KY, NM, PA, TN, and SD.

Product description

Titanium MPJ (Toe Implant) TOE JOINT TITANIUM PC MD, Part ID 17036

Code information (models, lots, serial numbers)

Lot Number: 127603, 125590; UDI: 00810012480246

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Other devices under the same FDA submission

6 devices cleared under K041595 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 89605).

Sources and updates

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