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Skytron Split Leg Pad Set 3"

COMPOSITE MANUFACTURING, INC. · Model 4-030-70-3S · UDI-DI 00810105030655

BWN

510(k) clearances

225

Adverse events (1 deaths)

Recalls

153

Facilities

Description

3" Pad Set for Skytron Split Leg.

Recalls

Date	Firm	Reason
2026-07-24	QUANTUM OPS Inc	Due to a manufacturing issue (inadequate weld) for patient head positioning system.
2021-09-13	Innovative Orthopedic Technologies, LLC	Due to the holes not being bored to the specific diameter, the locking pins are unable to engage under a load.
2016-10-06	The Anspach Effort, Inc.	Supplied Directions for Use (DFU) did not contain a recommended service interval.
2016-10-06	The Anspach Effort, Inc.	Supplied Directions for Use (DFU) did not contain a recommended service interval.
2016-10-06	The Anspach Effort, Inc.	Supplied Directions for Use (DFU) did not contain a recommended service interval.
2016-10-06	The Anspach Effort, Inc.	Supplied Directions for Use (DFU) did not contain a recommended service interval.
2016-10-06	The Anspach Effort, Inc.	Supplied Directions for Use (DFU) did not contain a recommended service interval.
2016-10-06	The Anspach Effort, Inc.	Supplied Directions for Use (DFU) did not contain a recommended service interval.
2016-10-06	The Anspach Effort, Inc.	Supplied Directions for Use (DFU) did not contain a recommended service interval.
2016-10-06	The 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.