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Screw Removal Kit

GM DOS REIS INDUSTRIA E COMERCIO LTDA · Model Sterile Screw Removal Kit - T10/T15 · UDI-DI 07899258695211

HWB Prescription
5
510(k) clearances
3,487
Adverse events
4
Recalls
274
Facilities

Recalls

DateFirmReason
2024-03-07Innomed, Inc.54 MM finisher blade was inadvertently affixed to the shaft of the CupX handle in lieu of the 54 MM starter blade.
2018-03-19Synthes, Inc.There is a potential for the connection screw of the stem extractor to break.
2010-11-10Encore Medical, LpRevision A and B CLP Extraction Hooks may fracture at the distal end, resulting in surgical delay.
2010-03-02Stryker Howmedica Osteonics Corp.Literature did not include the design change to a smaller cannulation diameter.

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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.