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General Instruments

ALPHATEC SPINE, INC. · Model CI-11920 · UDI-DI 00840180543733

HWN Prescription

510(k) clearances

822

Adverse events

Recalls

167

Facilities

Description

Locking Spondy Reducer, Wide

Recalls

Date	Firm	Reason
2010-02-16	Zimmer Inc.	The firm determined that the recalled instruments were manufactured using the wrong grade of material. As manufactured, the instruments are more brittle, increasing the potential
2010-02-16	Zimmer Inc.	The firm determined that the recalled instruments were manufactured using the wrong grade of material. As manufactured, the instruments are more brittle, increasing the potential
2010-02-16	Zimmer Inc.	The firm determined that the recalled instruments were manufactured using the wrong grade of material. As manufactured, the instruments are more brittle, increasing the potential
2010-02-16	Zimmer Inc.	The firm determined that the recalled instruments were manufactured using the wrong grade of material. As manufactured, the instruments are more brittle, increasing the potential
2010-02-16	Zimmer Inc.	The firm determined that the recalled instruments were manufactured using the wrong grade of material. As manufactured, the instruments are more brittle, increasing the potential
2010-02-16	Zimmer Inc.	The firm determined that the recalled instruments were manufactured using the wrong grade of material. As manufactured, the instruments are more brittle, increasing the potential
2010-02-16	Zimmer Inc.	The firm determined that the recalled instruments were manufactured using the wrong grade of material. As manufactured, the instruments are more brittle, increasing the potential
2010-02-16	Zimmer Inc.	The firm determined that the recalled instruments were manufactured using the wrong grade of material. As manufactured, the instruments are more brittle, increasing the potential
2010-02-16	Zimmer Inc.	The firm determined that the recalled instruments were manufactured using the wrong grade of material. As manufactured, the instruments are more brittle, increasing the potential

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Data 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.