FDA Medical Device Recalls (openFDA)
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. 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 number
- Z-1506-06
- Recalling firm
- J. Jamner Surgical Instruments, Inc.
- Product
- 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.
- Status
- Terminated
- Initiated
- 2006-04-24
- Posted
- 2006-09-16
- Terminated
- 2006-09-15
- 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.
- Lot, serial or model codes
- The affected product can be identified by the following code on the product label: 143 60173 6.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FWZ
- Firm FEI
- 2430952
- Firm city
- Hawthorne
- Firm state
- NY
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28