FDA Device recall Z-2056-2013
Integra Leyla Ball Joint Clamp, also as included in Leyla Table Mounting Hardware
- FDA Device
- Class II
- terminated
- Published 2013-09-04
On 2013-09-04 the FDA classified a Class II recall of Integra Leyla Ball Joint Clamp, also as included in Leyla Table Mounting Hardware by Integra, citing 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 mainta….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2056-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-07-17 |
| Published | 2013-09-04 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Integra |
| Distribution | AZ, CA, FL, GA, IL, IN, KY, MA, MI, MS, NE, NM, NY, OH, PA, PR, TN, TX, UT, VA, WA, WI, WV |
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
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.
Identifiers
| code_info | Catalog Number R2383 and as a component of catalog number R2385, including all lot numbers date codes going back to January 2006. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2056-2013%22
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