Recall Z-0684-2022 ยท KWD Prosthesis, Toe, Hemi-, Phalangeal
BioPro, Inc.
Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC ML, Part ID 16815
| Date | Feb 1, 2022 |
| Status | Terminated |
| 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. |
| Root cause | Labeling design |
| Action | 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 ref |
| Distribution | US Nationwide distribution in the states of CT, KY, NM, PA, TN, and SD. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K041595 | TOE MP JOINT, MODELS 10412-10414, 14958, 14960, 1060-10062,16818,-16822,16867-16870 Biopro, Inc., Nov 12, 2004 |