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Ambler Surgical

AMBLER SURGICAL CORP. · Model Chang-Seibel nucleus chopper · UDI-DI 00190660010294

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510(k) clearances

109

Adverse events

Recalls

187

Facilities

Description

Chang-Seibel nucleus chopper, 5 3/8'', double-ended, angled shafts, 10.0mm from bend to tips, combo vertical safety chopper with thin paddle and horizontal chopper with finger-shaped tip, for use in the right hand, round handle, titanium

Recalls

Date	Firm	Reason
2025-12-16	Vortex Surgical Inc.	There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination
2025-12-16	Vortex Surgical Inc.	There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination
2024-12-03	Sklar Instruments	Reports of various packaging issues that may result in a breach of the sterile barrier.
2022-03-16	Carl Zeiss Meditec AG	High friction of the slider can cause the device to stick, or not move as intended.

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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.