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.
FDA Recall Z-2056-2013 · Posted 2013-08-26
Recalling FirmIntegra Limited
Recall StatusTerminated
Product CodeHBG
Date Initiated2013-07-17
Date Terminated2014-10-01
Product Quantity65
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.
Firm 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.
Root Cause
Device Design
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.