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Cortical Counter Sink

I.T.S. GmbH · Model 63408 · UDI-DI 09120047300916

HWW
0
510(k) clearances
15
Adverse events
17
Recalls
112
Facilities

Description

Cortical Counter Sink, for HCS D=3.5mm

Recalls

DateFirmReason
2019-04-08Zimmer GmbHAn investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
2019-04-08Zimmer GmbHAn investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
2019-04-08Zimmer GmbHAn investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
2019-04-08Zimmer GmbHAn investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
2019-04-08Zimmer GmbHAn investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
2019-04-08Zimmer GmbHAn investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
2019-04-08Zimmer GmbHAn investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
2019-04-08Zimmer GmbHAn investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
2019-04-08Zimmer GmbHAn investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
2019-04-08Zimmer GmbHAn investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.

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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.