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Richard Wolf GmbH · Model 499751305 · UDI-DI 04055207053744

HWE

510(k) clearances

50,440

Adverse events (7 deaths)

101

Recalls

385

Facilities

Description

BURR ROUND Ø 5.5MM PACK=5 PCS, WL 290mm, for use with motor handpieces M5/0 and M5/3, for extraction of bony structures, in endoscopic spine surgery, sterile, for single use

Recalls

Date	Firm	Reason
2018-09-19	Encore Medical, Lp	Manufacturing error, the drill bit shaft is unable to properly capture the drill bit pin. Failure of the drill bit shaft to capture the drill bit pin could result in the drill bi
2017-09-29	The Anspach Effort, Inc.	This voluntary recall was initiated because a veterinary unit was physically shipped in error to a non-veterinary customer account.
2017-05-22	Zimmer Biomet, Inc.	Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increa
2017-05-22	Zimmer Biomet, Inc.	Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increa
2017-05-22	Zimmer Biomet, Inc.	Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increa
2017-05-22	Zimmer Biomet, Inc.	Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increa
2017-05-22	Zimmer Biomet, Inc.	Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increa
2017-05-22	Zimmer Biomet, Inc.	Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increa
2017-05-22	Zimmer Biomet, Inc.	Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increa
2017-05-22	Zimmer Biomet, Inc.	Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increa

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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.