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Trigger Lite Armboard

COMPOSITE MANUFACTURING, INC. · Model 2-010-10 · UDI-DI 00810105030587

BWN
10
510(k) clearances
225
Adverse events (1 deaths)
74
Recalls
152
Facilities

Description

Carbon Fiber construction Armboard designed to integrate with surgical table side rail and support the patient arm for surgical procedures.

Recalls

DateFirmReason
2021-09-13Innovative Orthopedic Technologies, LLCDue to the holes not being bored to the specific diameter, the locking pins are unable to engage under a load.
2016-10-06The Anspach Effort, Inc.Supplied Directions for Use (DFU) did not contain a recommended service interval.
2016-10-06The Anspach Effort, Inc.Supplied Directions for Use (DFU) did not contain a recommended service interval.
2016-10-06The Anspach Effort, Inc.Supplied Directions for Use (DFU) did not contain a recommended service interval.
2016-10-06The Anspach Effort, Inc.Supplied Directions for Use (DFU) did not contain a recommended service interval.
2016-10-06The Anspach Effort, Inc.Supplied Directions for Use (DFU) did not contain a recommended service interval.
2016-10-06The Anspach Effort, Inc.Supplied Directions for Use (DFU) did not contain a recommended service interval.
2016-10-06The Anspach Effort, Inc.Supplied Directions for Use (DFU) did not contain a recommended service interval.
2016-10-06The Anspach Effort, Inc.Supplied Directions for Use (DFU) did not contain a recommended service interval.
2016-10-06The Anspach Effort, Inc.Supplied Directions for Use (DFU) did not contain a recommended service interval.

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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.