DTE
Guilin Woodpecker Medical Instrument Co., Ltd. · Model Implanter · UDI-DI 06944843662473
1
510(k) clearances
392
Adverse events
2
Recalls
69
Facilities
Description
Mechanical drive unit with coolant supply for transmission instruments with ISO 3964 (DIN13940) compatible coupling system, for use in dental surgery, implantology and maxillofacial surgery (CMF) for treatment of dental hard tissue.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2017-12-21 | W & H DentalWerk Burmoos GMBH - Site 1 | During continuous postmarket surveillance activities, we have noticed a potential malfunction of individual foot controls of the type S-N1/S-N2. In case the error occurs, the foot |
| 2013-10-24 | Nobel Biocare Usa Llc | The recall was initiated because there is a potential for malfunction of the OsseoCare Pro when used with the OseeoCare Pro iPad application software release 1.2.0.7. |
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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.