FDA Medical Device Recalls (openFDA)
Integra Limited: Integra Leyla Ball Joint Clamp, also as included in Leyla Table Mounting Hardware. The Leyla Retraction System, as part of the Ruggles brand of instruments is intended for use as a self-retaining retractor which is a self-locking device used to hold the edges of a wound open during neurosurgery.
- Recall number
- Z-2056-2013
- Recalling firm
- Integra Limited
- Product
- Integra Leyla Ball Joint Clamp, also as included in Leyla Table Mounting Hardware. The Leyla Retraction System, as part of the Ruggles brand of instruments is intended for use as a self-retaining retractor which is a self-locking device used to hold the edges of a wound open during neurosurgery.
- Status
- Terminated
- Initiated
- 2013-07-17
- Posted
- 2013-08-26
- Terminated
- 2014-10-01
- Reason
- As a result of complaint investigations it was identified that there is a potential that the Leyla Ball Joint Clamp (R2383) may not provide the level of stability needed to maintain retraction in all cases.
- Root cause
- Device Design
- Action
- Integra sent an Urgent Medical Device letter dated July 17, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were requested to review your inventory and determine if you have any of the affected products. If so, stop using them immediately and remove them from your service. When your form is received, Customer Service will you an RMA number and directions for returning the products. Should you have any questions regarding these instructions, please contact Integra Customer Service at 1-800-997-4868.
- Quantity
- 65
- Distribution
- Worldwide Distribution - USA including Puerto Rico and the states of AZ, CA, FL, GA, IL, IN, KY, MA, MI, MS, NE, NM, NY, OH, PA, TN, TX, UT, VA, WA, WI and WV., and the countries of Spain, Singapore, South Africa, Canada, Libya,Pakistan and Cayman Islands.
- Lot, serial or model codes
- Catalog Number R2383 and as a component of catalog number R2385, including all lot numbers date codes going back to January 2006.
- 510(k) numbers
- ["K902818"]
- PMA numbers
- not on file
- Product code
- HBG
- Firm FEI
- 3001700044
- Firm city
- Plainsboro
- Firm state
- NJ
- 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