Craniotome

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