Recall Z-1247-2022 ยท LXH Orthopedic Manual Surgical Instrument
Medacta Usa Inc
GMK Efficiency - GMK Sphere CR Insert Instrument Set Size 1
| Date | Apr 13, 2022 |
| Status | Terminated |
| Reason | A Size 2 trial baseplate was assembled with Size 1 instrument sets. |
| Root cause | Nonconforming Material/Component |
| Action | The recalling firm emailed their sales agents on 4/13/2022 to notify them the implants were associated with a recall and must be returned immediately to the recalling firm. It also said that replacements are currently on order and will be overnighted to them once they are available. A copy of the Field Safety Notice from the manufacturer was forwarded to the sales agents. The Notice informed them the three affected lots have been assembled following an incorrect packing list, resulting in a size 2 trial baseplate being inserted in a size 1 instrument set, and that all the other devices incl |
| Quantity | 50 units |
| Distribution | Distribution was made to AK, CA, CT, IN, MA, NJ, and PA. There was no foreign/military/government distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.