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Trenstop

COMPOSITE MANUFACTURING, INC. · Model 1-1002-001 · UDI-DI 00810105030273

BWN
10
510(k) clearances
225
Adverse events (1 deaths)
75
Recalls
155
Facilities

Description

Carbon Fiber Trendelenburg restraint table accessory. Designed for preventing patient movement while using the Trendelenburg position for surgical procedures. Device is attached to the operating table's side rails via accessory clamps.

Recalls

DateFirmReason
2026-07-24QUANTUM OPS IncDue to a manufacturing issue (inadequate weld) for patient head positioning system.
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.

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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.