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. The Table Mounting Hardware are attachments to operating room surgical tables. The product is supplied non-sterile and may be packaged individually or as part of the Table Mount Set.
Recall
- Recall Number
- Z-1506-06
- Event Number
- 36031
- Firm
- J. Jamner Surgical Instruments, Inc.
- FEI Number
- 2430952
- Product Code
- FWZ
- Status
- Terminated
- Root Cause
- Other
- Initiated
- April 24, 2006
- Posted
- September 16, 2006
- Terminated
- September 15, 2006
- Address
- 9 Skyline Drive, Hawthorne, NY, 10532-2100
Description
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. The Table Mounting Hardware are attachments to operating room surgical tables. The product is supplied non-sterile and may be packaged individually or as part of the Table Mount Set.
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.
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.
5 hospitals in MS, IL, WI and TX, and 1 salesman in IL.
8 units