Skip to content

DIEGO ELITE recallZ-1337-2018 · Gyrus ACMI, Inc. · initiated Aug 3, 2017

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Gyrus ACMI, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

"Chattering" when cutting burrs are used in bone.

What the company is doing

As a result, OSTA will issue a Field Safety Notice (FSN) to all customers that received variable exposure burrs of 5mm or greater diameter. The FSN will inform them of the concern and will advise to exercise due caution if using the affected device in proximity to sensitive or vital anatomical structures. On September 6, 2017 the firm sent a URGENT: MEDICAL DEVICE FIELD SAFETY NOTICE to the attention of the Surgical Risk Management Department for the following products: MBUR5060FRCV - Burr, 5mm Round Cutting, Variable Exposure, Standard Length, MBUR6060FRCV - Burr, 6mm Round Cutting, Variable Exposure, Standard Length and MBUR7060FRCV - Burr, 7mm Round Cutting, Variable Exposure, Standard Length for All product with an expiration date prior to August 3, 2017 Description of the problem: Olympus has become aware of an issue that requires your attention. This letter pertains to the Olympus Round Variable Cutting Burrs (Burrs) referenced above. Our records indicate that you may have purchased affected burrs. We are in receipt of a number of non-injury-related complaints that has made Olympus aware of a possibility that the burr may chatter when drilling bone. Although this chatter phenomenon can occur with any type or brand of cutting burr, depending on technique and bone density, Olympus has become aware that the larger diameter variable exposure burrs listed above can exhibit more chatter than other similar devices in some situations, particularly when they are extended to longer lengths. After extensive testing, Olympus has determined that our variable exposure burrs of less than 5mm diameter, and all fixed exposure burr offerings, are not affected by this phenomenon. Because of this, Olympus has elected to issue this field safety notice (FSN). Please refer to the enclosure with this letter that cautions of the possibility of the chatter phenomenon in the larger variable offerings. The FSN also recommends that surgeons exercise due caut

Recall details

Recall number
Z-1337-2018
Status
Open, Classified
Initiated by the company
Aug 3, 2017
Posted by the FDA
Mar 20, 2018
Recalling firm
Gyrus ACMI, Inc.
Quantity
324
Product code
EQJ
Distribution
NM, MI, and TX EU, Australia, Japan, and Hong Kong

Product description

Gyrus ACMI Round Cutting Burrs - to be used with the Diego Elite system

Code information (models, lots, serial numbers)

Catalog No. (UDI-DI): MBUR5060FRCV (00821925036529), MBUR6060FRCV (00821925036536), and MBUR7060FRCV (00821925036543) ALL LOTS MANUFACTURED BEFORE AUGUST 3, 2017

Devices named in this recall

3 devices in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page