Integra UCR 3mm Hex, Large Axial Driver. The UCR Hex Axial Driver is a surgical instrument used to implant and remove po
FDA device recall Z-1841-2014 · posted 2014-06-20 · Terminated
Recall details
- Recalling firm
- SeaSpine Inc
- Reason for recall
- Integra has identified through an investigation of complaints that there may be the potential for the tip of a single lot number of the UCR 3mm Hex, Large Axial Driver, 91-1123 to twist or become rounded during use.
- Action taken
- Integra sent an Urgent Voluntary Medical Device Recall letter dated May 21, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed: 1. If you have distributed the affected product, identify those customers and forward the attached Integra Medical Device Recall Notice to them. 2. Inspect your inventory of UCR 3mm Hex, Large Axial Drivers (Catalogue Number: 91- 1123). If you have product with lot number MO16090B, STOP USING IMMEDIATELY. If you have product of any other lot number, you can continue to use it. The event has been isolated to this single lot. 3. We also request that regardless if you have a UCR Driver with the affected lot, you complete the attached form and return it to us as soon as possible as indicated. We recommend you keep a copy of the form for your records. 4. When your form is received, Customer Service will contact you and provide an RMA number, directions to return the product, and input an order to replace the quantity you indicate on the form. Should you have any questions regarding these instructions, please contact Customer Service at 1-866- 942-8698. We apologize for any inconvenience this may cause and thank you for your cooperation in this effort. : .
- Root cause
- Under Investigation by firm
- Status
- Terminated
- Product code
- NKB
- Quantity affected
- 7
- Distribution
- US Distribution including the states of : AL, CA, OH, NM and TN.
- Date initiated
- 2014-05-21
- Date posted
- 2014-06-20
- Date terminated
- 2014-12-15
- Location
- Vista, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| UCR SPINAL SYSTEM (K043232) | Seaspine | 2004-12-21 |