Rev E PedFuse Return Screw Inserter, Part Number: 11-80030 Screw inserters are instruments which capture, hold and drive
FDA device recall Z-1926-2013 · posted 2013-08-08 · Terminated
Recall details
- Recalling firm
- SpineFrontier, Inc.
- Reason for recall
- Inserters have a set screw that fixes a collar to the inserter. The screw set can loosen and fall out of the inserter which allows the collar to slide off the proximal end of the inserter. When the collar is not in place the locking sleeve can also slide off the inserter.
- Action taken
- Spine Frontier sent an email dated December 10, 2012, to the affected customers that a Pedfuse Inserter with part number PM3979 needed to be returned. Further questions please call (978) 232-3990.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- HXX
- Quantity affected
- 8
- Distribution
- Distribution only in Texas.
- Date initiated
- 2013-03-14
- Date posted
- 2013-08-08
- Date terminated
- 2015-06-03
- Location
- Beverly, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| KRD1 PEDICLE SCREW SYSTEM (K092420) | Spinefrontier, Inc. | 2009-11-19 |