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ATHLET
SIGNUS Medizintechnik GmbH · Model Height indicator · UDI-DI 04047844044643
HTS
Prescription
9
510(k) clearances
12
Adverse events
3
Recalls
117
Facilities
Description
An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-09-30 | Beaver 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 |
| 2009-11-11 | Stryker 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 |
| 2009-06-12 | Becton Dickinson and Company | Mislabeled: Arthro-Lok Pointed Tip 4mm Blade curving right instead of left. |
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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.