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Conmed Corporation · Model E4217 · UDI-DI 10845854022016
GFF
Prescription
10
510(k) clearances
2,110
Adverse events
13
Recalls
179
Facilities
Description
LINDEMANN BUR 1.6MM X 31MM
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2021-02-09 | In2Bones, SAS | This Field Action is being conducted following identification of manufacturing non-conformity of some batches of Shannon burrs diameter 2.0mm length 20mm, possibly causing the brea |
| 2019-10-18 | Brasseler USA I Lp | One lot of 3.5 mm twist drills were incorrectly laser etched as 2.5 mm the shaft of the device. |
| 2019-01-14 | Arthrex, Inc. | Devices may generate excessive heat during use. |
| 2016-11-08 | Wright Medical Technology, Inc. | The firm discovered a lack of adequate documentation confirming sterility on certain products. |
| 2016-10-06 | The Anspach Effort, Inc. | Supplied Directions for Use (DFU) did not contain a recommended service interval. |
| 2015-12-21 | ConMed Corporation | Metal shavings released from burs during use are due to contact between the bur and the hood of the PreBent Bur assembly. During the manufacturing process an assembly error occurr |
| 2015-02-11 | EXP Pharmaceutical Services Corp | EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact that its vendors were re |
| 2013-05-03 | Surgical Instrument Service And Savings, Inc. | The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch. |
| 2012-06-11 | The Anspach Effort, Inc. | Anspach was contacted by a hospital to inform Anspach that a Blackmax motor had been used in a case where the patient was diagnosed with Creutzfeldt-Jacob Disease (CJD). |
| 2011-03-31 | The Anspach Effort, Inc. | Cutter was longer than was stated on the label |
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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.