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Terminated

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.

FDA Recall Z-1506-06 · Posted 2006-09-16

Recalling FirmJ. Jamner Surgical Instruments, Inc.
Recall StatusTerminated
Product CodeFWZ
Date Initiated2006-04-24
Date Terminated2006-09-15
Product Quantity8 units

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.

Firm 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.

Root Cause

Other

Distribution Pattern

5 hospitals in MS, IL, WI and TX, and 1 salesman in IL.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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