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Klein Surgical
Klein Surgical Systems, Inc. · Model 300-400-775 · UDI-DI 10850048763309
GCI
Prescription
1
510(k) clearances
1,684
Adverse events (3 deaths)
5
Recalls
42
Facilities
Description
Klein Bulldog Applier 10mm
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2020-05-12 | Covidien Llc | The 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 |
| 2020-05-12 | Covidien Llc | The 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 |
| 2020-05-12 | Covidien Llc | The 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 |
| 2020-05-12 | Covidien Llc | The 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 |
| 2015-02-11 | EXP Pharmaceutical Services Corp | EXP 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 r |
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Get your free API keyRead the docsData 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.