Integra Leyla Ball Joint Clamp, also as included in Leyla Table Mounting Hardware. The Leyla Retraction System, as part
FDA device recall Z-2056-2013 · posted 2013-08-26 · Terminated
Recall details
- Recalling firm
- Integra Limited
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- HBG
- Quantity affected
- 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,
- Date initiated
- 2013-07-17
- Date posted
- 2013-08-26
- Date terminated
- 2014-10-01
- Location
- Plainsboro, NJ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MULTIPLE NONPOWERED NEUROSURGICAL INSTRUMENT (K902818) | Ruggles Corp. | 1990-09-20 |