Recall Z-2059-2017 ยท LXH Orthopedic Manual Surgical Instrument
Zimmer Biomet, Inc.
Bone Dowell Harvest Tubes
| Date | Apr 25, 2017 (initiated Apr 12, 2017) |
| Status | Terminated |
| Reason | mislabeled as 8mm tube but it is actually 9 mm in size. A 9mm subcomponent was erroneously substituted and etched as 8mm for the actual 8mm subcomponent part. |
| Root cause | Nonconforming Material/Component |
| Action | On 4/12/2017 URGENT MEDICAL DEVICE RECALL REMOVAL notifications were sent to the affected consignees via e-mail. 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. |
| Quantity | 49 |
| Distribution | No US distribution. JAPAN NETHERLANDS SINGAPORE SWITZERLAND |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.