Recall Z-0238-2019 ยท HWC Screw, Fixation, Bone
Synthes (USA) Products LLC
3.0mm Headless Compression Screw, Long Thread 18mm, Part Number 04.226.118 DePuy Synthes 3.0mm Headless Compression Screws are intended for fixation of intra-articular and extra-articular fractures and nonunions of small bones and small bone fragments.
| Date | Sep 12, 2018 |
| Status | Terminated |
| Reason | The product inside the package does not match the label. The product was labeled as long thread screws that have a 6mm thread length but were actually short thread screws with a 4mm thread length. |
| Root cause | Under Investigation by firm |
| Action | The FRIM, DePuy Synthes, sent an URGENT: MEDICAL DEVICE RECALL (REMOVAL)"letters dated 9/12/18 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to do the following: 1. Immediately review your inventory to identify and quarantine the subject product that is still in the original packaging in a manner that ensures the subject product will not be used. 2. Complete the attached Verification Section (page 3 of this notification). Please include your facility name and address, account number, name of person completing the form, title |
| Quantity | 20 |
| Distribution | US Distribution to the following states: AR, AZ, FL, IL, NM, OH, and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K050636 | SYNTHES 3.0MM HEADLESS COMPRESSION SCREWS Synthes (Usa), Apr 21, 2005 |