Integra Leyla Ball Joint Clamp — Class II medical device recall Z-2056-2013
Terminated recall by Integra Limited, reported 2013-09-04, distributed in AZ, CA, FL, GA, IL, IN, KY, MA…. As a result of complaint investigations it was identified that there is a potential that the Leyla Ball Joint
| Recall number | Z-2056-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Integra Limited, Plainsboro, NJ, United States |
| Recall initiated | 2013-07-17 |
| Classified | 2013-08-26 |
| Reported by FDA | 2013-09-04 |
| Terminated | 2014-10-01 |
| Distributed | AZ, CA, FL, GA, IL, IN, KY, MA, MI, MS, NE, NM, NY, OH, PA, PR, TN, TX, UT, VA, WA, WI, WV |
| Countries outside the US | CA, ES, KY, PK, SG, ZA |
| Quantity | 65 |
| Reason classes | specification failure |
| Model numbers | R2383, R2385 |
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.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2056-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.