Recall Z-0654-2016 ยท HRS Plate, Fixation, Bone
Zimmer Biomet, Inc.
Zimmer Universal Locking System 3.5mm Locking Reconstruction Plate Straight 11 Holes 144mm Length Zimmer Universal Locking System 3.5mm Locking Dual Compression Plate 8 Holes 105mm Length. Indicated for temporary internal fixation and stabilization of osteotomies and fractures.
| Date | Dec 9, 2015 |
| Status | Terminated |
| Reason | The product on the package label did not match what was inside the package. The label was for part number 00-4936-011-13 lot number 62968956 while the product inside the package was part number 00-4936-008-07 lot number 62968974. |
| Root cause | Labeling Change Control |
| Action | On 12/9/2015, URGENT MEDICAL DEVICE RECALL notifications were sent to the affected distributors and hospital risk managers via courier with instructions for identifying and returning the affected product. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Specifically, customers were asked to review the notification and ensure all affected personnel are aware of the information; assist the Zimmer Biomet sales representative with the quarantine and removal |
| Quantity | 52 |
| Distribution | Worldwide Distribution -- USA, including the states of MN, NY, MS, AL, OH, KY, ME, and NM; and, the countries of Taiwan, Korea, Singapore, El Salvador, Uruguay, Czech Republic, France, Italy, Poland, United Kingdom, South Africa, and Slovakia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K060710 | UNIVERSAL LOCKING SYSTEM, 3.5MM PLATES AND SCREWS-4936 PLATES,4835 SCREWS Zimmer, Inc., Apr 26, 2006 |