Recall Z-1921-2023 ยท LXH Orthopedic Manual Surgical Instrument
Howmedica Osteonics Corp.
Exeter V40 Trial Head, 26mm, -3, Catalog Number 6364-8-026
| Date | Jun 14, 2023 (initiated May 3, 2023) |
| Status | Open, Classified |
| Reason | The Exeter V40 Trial Head, catalog number 6364-8-026 (size 26mm, -3) may appear green, when it is meant to be a blue color. Green signifies a size 26mm, +3 Trial Head. |
| Root cause | Under Investigation by firm |
| Action | An URGENT MEDICAL DEVICE RECALL notification letter dated 5/3/23 was sent to customers. Actions Needed: Our records indicate that you may have received the affected product(s). It is Stryker s responsibility as the manufacturer to ensure that customers who may have received these affected products also receive this important communication. We therefore request that you read this notice carefully and complete the following actions. 1. Please inform users of this Urgent Medical Device Recall and forward this notice to all individuals who need to be made aware. 2. Immediately check all stock are |
| Quantity | 2 units |
| Distribution | International distribution in the country of Ireland. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.