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OP Response Spine System
ORTHOPEDIATRICS CORP. · Model 01-1301-6040 · UDI-DI 00840194445818
GFC
Prescription
2
510(k) clearances
101
Adverse events
2
Recalls
87
Facilities
Description
5.5/6.0 Closed Cannulated Pedicle Screw Driver, Zimmer Hudson
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2014-09-09 | Zimmer, Inc. | The Persona 48mm X 2.5mm Female Screw is being recalled due to potential use of the screw in cortical bone, and corresponding stripping of the 2.5mm Persona Hex Driver. |
| 2013-05-30 | Exactech, Inc. | When torque is applied to the Articulated Driver at the maximum angle, the cross pin may shift out of position, potentially leading to disassembly of the instrument. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.