Health product recall

Craniotome

Last updated

Summary

Product
Craniotome
Issue
Medical devices - Performance
What to do

Contact the manufacturer if you require additional information.

Audience
Healthcare

Affected products

Affected products

Lot or serial number

Model or catalog number

Craniotome 5

More than 10 numbers, contact manufacturer.

CRANI-P
CRANI-A
CRANI-L

Craniotome

More than 10 numbers, contact manufacturer.

CRANI-L-G1
CRANI-P-G1
CRANI-A-G1

Issue

Two complaints were received from China in which ball bearings in the Crani-a (anspach power tools adult craniotome attachment) came out of the attachment, possibly during removal of the attachment, intra-operatively. Exact circumstances are unknown. However, the affected attachments were used well beyond the recommended service interval of 12 months. Use of the anspach craniotome attachments outside of the required service interval and/or displaying end of life indicators may result in device damage. Extreme care must be exercised to ensure that if damage occurs and fragments are released from the damaged device, then the surgical field must be examined to prevent foreign bodies from being left in the patient.

Recall start date: December 14, 2022

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - General and plastic surgery
Health products - Medical devices - Orthopaedics
Companies

The Anspach Effort Inc.

4500 Riverside Dr., Palm Beach Gardens, Florida, United States, 33410

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-72504

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