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MEDLINE RENEWAL

MEDLINE INDUSTRIES, INC. · Model 80000027RH · UDI-DI 10080196392575

HTS Prescription
9
510(k) clearances
12
Adverse events
3
Recalls
117
Facilities

Description

8000-0027 PATELLA CTR,SST 27 MM X 12M

Recalls

DateFirmReason
2022-09-30Beaver Visitec International, Inc.Incorrect configuration of the blades in the package. The blades curve to the right instead of curving to the left. If used may cause cause unintended tissue damage during the proc
2009-11-11Stryker Howmedica Osteonics Corp.Disposable Patella Cutters - 30 mm (catalog number 8000-0030, lot V31257001) were packaged and labeled as 33 mm Disposable Patella Cutters (catalog number 8000-0033, lot V31257001
2009-06-12Becton Dickinson and CompanyMislabeled: Arthro-Lok Pointed Tip 4mm Blade curving right instead of left.

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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.