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Endoskeletal Components

COLLEGE PARK INDUSTRIES, INC. · Model 4HLP RHD S · UDI-DI 00841747181771

IQO
0
510(k) clearances
48
Adverse events
2
Recalls
47
Facilities

Description

4-Hole Lamination Plate, Round, Heavy Duty, SS

Recalls

DateFirmReason
2012-07-27Biomet U.K., Ltd.A drafting error during an unrelated design change has led to 4 misleading dimensions on the drawing. The CAD model remained the same thickness but the problem dimensions were acci
2007-09-11Stryker Howmedica Osteonics Corp.The bubble in a vial of the Pelvic Alignment Level (PAL) was wider than the level marking. Upon opening the PAL and removing the vial, it was discovered that the vial was leaking

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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.