Recall Z-1506-06 ยท FWZ Operating Room Accessories Table Tray
J. Jamner Surgical Instruments, Inc.
Ruggles Leyla Ball Joint Clamp, MODEL/CATALOG #: R2383 . The Leyla Ball Joint Clamp is part of the Table Mounting Hardware that is used with the Leyla Retractor System. The Leyla Table Mounting Hardware consists of the Ball Joint Clamp, the Rigid Holding Rod, the Coupling Head, and the Coupling Head Turn Table. The Ball Joint Clamp is available individually or as part of the Table Mount Set.
| Date | Sep 16, 2006 (initiated Apr 24, 2006) |
| Status | Terminated |
| Reason | The Ruggles Leyla Ball Joint Clamp may not properly tighten onto the Rigid Holding Rod. Although this condition can be observed during assembly, if the device were to be used during surgery, any attachments to the Rigid Holding Rod could move. |
| Root cause | Other |
| Action | On 4/24/06, Integra LifeSciences Corp. sent an 'URGENT - RECALL NOTICE' letter (dated 4/24/06) and a 'RECALL ACKNOWLEDGEMENT' Form to the 5 hospitals and 1 salesman that received the product. |
| Quantity | 8 units |
| Distribution | 5 hospitals in MS, IL, WI and TX, and 1 salesman in IL. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.