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Klein Surgical

Klein Surgical Systems, Inc. · Model 300-100-789 · UDI-DI 10850048763286

GCI Prescription
1
510(k) clearances
1,682
Adverse events (3 deaths)
5
Recalls
42
Facilities

Description

Endoscopic Bulldog Clamp 60mm

Recalls

DateFirmReason
2020-05-12Covidien LlcThe product is recalled due to a manufacturing assembly error that may cause the staples to fail to properly advance within the staple cartridge when the instrument handle is compr
2020-05-12Covidien LlcThe product is recalled due to a manufacturing assembly error that may cause the staples to fail to properly advance within the staple cartridge when the instrument handle is compr
2020-05-12Covidien LlcThe product is recalled due to a manufacturing assembly error that may cause the staples to fail to properly advance within the staple cartridge when the instrument handle is compr
2020-05-12Covidien LlcThe product is recalled due to a manufacturing assembly error that may cause the staples to fail to properly advance within the staple cartridge when the instrument handle is compr
2015-02-11EXP Pharmaceutical Services CorpEXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact that its vendors were re

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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.