Ruggles Leyla Ball Joint Clamp, MODEL/CATALOG #: R2383 . The Leyla Ball Joint Clamp is part of the Table Mounting Hardwa
FDA device recall Z-1506-06 · posted 2006-09-16 · Terminated
Recall details
- Recalling firm
- J. Jamner Surgical Instruments, Inc.
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- FWZ
- Quantity affected
- 8 units
- Distribution
- 5 hospitals in MS, IL, WI and TX, and 1 salesman in IL.
- Date initiated
- 2006-04-24
- Date posted
- 2006-09-16
- Date terminated
- 2006-09-15
- Location
- Hawthorne, NY
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