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TIPCONTROL

Richard Wolf GmbH · Model 899703754 · UDI-DI 04055207035849

HWE

510(k) clearances

50,440

Adverse events (7 deaths)

101

Recalls

385

Facilities

Description

ARTICULATING BURR Ø 4MM PACK = 1 PC, WL 290 mm, combinable with TipControl burr insert, for use with the motor handpiece M4, for extraction of bony structures, in endoscopic spine surgery, reusable

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.