Recall Z-1064-2018 ยท HWC Screw, Fixation, Bone
Zimmer Biomet, Inc.
6.5mm x 125mm x 16mm Cannulated Screw, Item Number: 110009948 (UDI: (01)00887868111327 (17)270421 (10)120910) Product Usage: The 6.5/8.0mm Cannulated Screw System is part of a series of cannulated screws ranging from 4.0 to 8.0mm. Used in Slipped capital femoral epiphysis, Pediatric femoral neck fractures, Tibial plateau fractures, SI joint disruptions, Intercondylar femur fractures, Subtalar art
| Date | Dec 7, 2017 |
| Status | Terminated |
| Reason | One lot of 3.5mm x 24mm Cortical Locking screws is labeled as 6.5mm x 125mm x 16mm Cannulated screws. |
| Root cause | Error in labeling |
| Action | Zimmer Biomet sent an Urgent Medical Device Recall letter dated December 2017 to their customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to: 1. Review this notification n and ensure that affected team members are aware of the contents. 2. Immediately locate and quarantine affected product in your inventory. 3. Immediately return all affected product from your distributorship and from affected hospitals within your territory. a. Complete Attachment 1 Inventory Return Certification Form and send to CorporateQuality.PostMarket@z |
| Quantity | 6 |
| Distribution | Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K140891 | BIOMET CANNULATED SCREW SYSTEM Biomet, Inc., Jun 3, 2014 |