Recall Z-0634-2022 ยท LXH Orthopedic Manual Surgical Instrument
Synthes (USA) Products LLC
Universal Chuck-The Universal Chuck is an Instrument Handle provided as an alternative instrument available for use in the TN-ADVANCED" Tibial Nailing System (TNA), TFN-ADVANCED" Proximal Femoral Nailing System (TFNA), RFN-ADVANCED" Retrograde Femoral Nailing System (RFNA), FRN-ADVANCED" Femoral Recon Nailing System (FRNA), and Flexible Monobloc Reamers. Instrument Handles are intended for holding
| Date | Dec 22, 2021 |
| Status | Open, Classified |
| Reason | Top cap may loosen and detach if the Universal Chuck becomes jammed and the user attempts to manually free the device, internal ball bearings may fall out onto the surgical field and cause surgical delay or, and if not recovered, adverse tissue reaction and infection. |
| Root cause | Device Design |
| Action | Depuy Synthes issued Urgent Medical Device Recall (Removal) issued on 12/22/21 via email FedX. Letter states reason for recall, health risk and action to take: 1. Examine your inventory immediately to determine if you have the subject products and quarantine the subject product. DO NOT USE THE SUBJECT PRODUCT. 2. Contact your DePuy Synthes Sales Consultant or call the customer support services at 1-800-479-6329 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.j |
| Quantity | 600 units |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.