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FASSIER-DUVAL TELESCOPIC IM SYSTEM
Orthopediatrics Canada ULC · Model PRO132-140 · UDI-DI 07540194007162
HTJ
Prescription
4
510(k) clearances
3,468
Adverse events
3
Recalls
372
Facilities
Description
PROBE Ø3.2mm AND Ø4.0mm
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2019-05-28 | Zimmer Biomet, Inc. | There is a potential for weak seals of the sterile packaging. |
| 2011-01-27 | Stryker Howmedica Osteonics Corp. | Stryker Orthopaedics has become aware that the 10 mm on the bone remaining depth gage is incorrect thus allowing for the reamer to leave as little as 8.9mm (in a nominal condition) |
| 2009-12-22 | Stryker Howmedica Osteonics Corp. | The Depth Measuring Gauges have 5 scale marking instead of the required 4 scale markings. |
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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.