Recall Z-0008-2023 ยท JDR Staple, Fixation, Bone
Synthes (USA) Products LLC
Hammertoe Continuous Compression Implant (CCI) Kit Part Number: 46.239.001
| Date | Oct 6, 2022 (initiated Aug 30, 2022) |
| Status | Open, Classified |
| Reason | Drill Pin (drill bit) is not compatible with the Drill Template included in the kit due to a packaging error, result in a surgical delay and may cause soft tissue damage if a larger incision is required to accommodate an alternative form of fixation. Additionally, there is a potential for adverse tissue reaction if the surgeon attempts to use the guide regardless of tight fit and plastic debris is created and ends up in the wound |
| Root cause | Employee error |
| Action | DePuy Synthes issued Urgent Medical Device Recall (Removal) letter on 8/30/22. Letter states reason for recall, health risk and action to take: 1. Examine your inventory immediately to determine if you have the subject product and quarantine. DO NOT USE THE SUBJECT PRODUCT. 2. Contact your DePuy Synthes Sales Consultant or call the customer support services at 1-800-255-2500 to coordinate the return/credits of the subject product. 3. Review, complete, sign, and return the attached Business Response Form (page 3 of this letter) to OneMD-Field-Actions@its.jnj.com within 3 business days of receip |
| Quantity | 191 units |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K191463 | DePuy Synthes Hammertoe Continuous Compression Implant Synthes (USA) Products, LLC, Feb 26, 2020 |