Recall Z-2056-2013 ยท HBG Drills, Burrs, Trephines & Accessories (Manual)
Integra Limited
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.
| Date | Aug 26, 2013 (initiated Jul 17, 2013) |
| 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. |
| 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 1-800-997-48 |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K902818 | MULTIPLE NONPOWERED NEUROSURGICAL INSTRUMENT Ruggles Corp., Sep 20, 1990 |