Class II — Integra Limited
| Recalling firm | Integra LifeSciences Corporation |
|---|---|
| Registered facility | View this company's 15 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| 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. |
| 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. |
| 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. |
| Initiated | 2013-07-17 |
| Classified | 2013-08-26 |
| Terminated | 2014-10-01 |
| Recall number | Z-2056-2013 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Integra Limited (Z-2056-2013).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/65824/
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