FDA Device Intelligence
Home › ALPHATEC SPINE, INC. › General Instruments

General Instruments

ALPHATEC SPINE, INC. · Model CI-10161-100-1600 · UDI-DI 00811801034756

HTZ Prescription
10
510(k) clearances
1,496
Adverse events
27
Recalls
230
Facilities

Description

Short Single Sided Endplate Scraper - Straight

Recalls

DateFirmReason
2020-01-03DePuy Orthopaedics, Inc.The device will not connect to the Specialist 2 Locating Outrigger which renders them unusable in surgery.
2015-07-01The Anspach Effort, Inc.Saw head separated from the drive unit or began to come loose.
2014-04-22Synthes, Inc.It was discovered internally that the face of the Synthes Matrix Mandible Short Cut Plate Cutter has the potential for discoloration/corroded material in the affected lot.
2013-08-13Tornier, IncFollowing the identification of the disassociation of an impactor tip during surgery, Tornier is initiating a voluntary recall of all lots of Aequalis Reversed II and Reversed Frac
2008-12-18Biomet, Inc.Falling component: The universal pin, which holds the sliding instrument saw guide in its slot, may loosen during surgical procedures and fall into the wound.
2008-12-18Biomet, Inc.Falling component: The universal pin, which holds the sliding instrument saw guide in its slot, may loosen during surgical procedures and fall into the wound.
2008-12-18Biomet, Inc.Falling component: The universal pin, which holds the sliding instrument saw guide in its slot, may loosen during surgical procedures and fall into the wound.
2008-12-18Biomet, Inc.Falling component: The universal pin, which holds the sliding instrument saw guide in its slot, may loosen during surgical procedures and fall into the wound.
2008-12-18Biomet, Inc.The Falling component: universal pin, which holds the sliding instrument saw guide in its slot, may loosen during surgical procedures and fall into the wound.
2008-12-18Biomet, Inc.Falling component: The universal pin, which holds the sliding instrument saw guide in its slot, may loosen during surgical procedures and fall into the wound.

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API keyRead the docs
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.