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Pediatric Arm and Hand Table, Wide with 2" Pad

COMPOSITE MANUFACTURING, INC. · Model 1-1018-001 · UDI-DI 00810105030358

BWN
10
510(k) clearances
225
Adverse events (1 deaths)
75
Recalls
153
Facilities

Description

Carbon fiber construction radiolucent surgical table attachment sized for pediatric patients. Attached to surgical table via clamp to table side rail.

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.