Recall Z-0956-2017 ยท HRY Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
Zimmer Biomet, Inc.
Oxford Fixed Lateral Bearing Size F Right, Part Number 154375 Lot 744260, Sterile, The product is placed into an Aluminum Oxide coated PET pouch and vacuum sealed with an Argon flush. The vacuum sealed part is then placed into a coated 1073B Tyvek/film pouch and heat sealed. This pouch acts as the sterile barrier. The pouch is then labeled and placed into a carton with an IFU. The carton is then l
| Date | Jan 6, 2017 (initiated Dec 6, 2016) |
| Status | Terminated |
| Reason | Zimmer Biomet is initiating a removal of a single lot of Oxford Fixed Lateral Bearings due to mislabeling. Zimmer Biomet received product complaints reporting that when the package labeled as a Right was opened it actually contained a Left Bearing. |
| Root cause | Employee error |
| Action | Zimmer Biomet sent an Urgent Medical Device Recall letter dated December 6, 2016. to all affected customers for a single lot of Oxford Fixed Lateral Bearings via e-mailed letter. Zimmer Biomet received two product complaints reporting that when the package labeled as a Right was opened it actually contained a Left Bearing. Risks: If another bearing is not available, a delay greater than 30 minutes may occur. If the product of the incorrect orientation is implanted, premature revision may be required. Customers were instructed to review the recall notification and ensure affected team members |
| Quantity | 12 units distributed |
| Distribution | Domestic: None Froeign: Netherlands & Switzerland VA/DOD: None |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K133940 | OXFORD FIXED LATERAL BEARING PARTIAL KNEE REPLACEMENT (BEARINGS / TRAYS) Biomet UK, Ltd., Mar 28, 2014 |