Z-2056-2013Class II

Integra Leyla Ball Joint Clamp, also as included in Leyla Table Mounting Hardware. The Leyla Retraction...

Name: Z-2056-2013 Integra Leyla Ball Joint Clamp, also as included in Leyla Table Mounting Hardware. The Leyla Retraction...
Creator: Integra Limited
Published: 2013-07-17
License: https://open.fda.gov/license/

Integra Lifesciences Sales LLC / initiated 2013-07-17 / Terminated / root cause: design

FDA source

Integra Limited began a recall of 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... on 2013-07-17. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2056-2013
Classification: Class II
Status: Terminated
Initiated: 2013-07-17
Posted: 2013-08-26
Terminated: 2014-10-01
Recalling firm: Integra Lifesciences Sales LLC
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.
Product code: HBG Drills, Burrs, Trephines & Accessories (Manual)
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.
Root cause tag: design
FDA 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 in commerce: 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.
Product codes and lots: Catalog Number R2383 and as a component of catalog number R2385, including all lot numbers date codes going back to January 2006.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2056-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2056-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-04	2013-08-26

Product code HBG

K902818Class IIMultiple Nonpowered Neurosurgical InstrumentRuggles Corp. / cleared 1990-09-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)