Recall Z-0916-2023— The Anspach Effort, Inc.

Name: FDA recall Z-0916-2023
Creator: U.S. Food and Drug Administration
Published: 2022-12-07

Class II · Ongoing

Class II FDA medical device recall by The Anspach Effort, Inc., initiated 2022-12-07. It names 2 FDA 510(k) clearances: K133604, K011444. Product: 6.5 cm Adult Rotating Craniotome Attachment. Use with XMax¿, microMax, and eMax¿ Systems. Ref: CRANI-A Intended for cutting and shaping bone including the spine and cranium. Reason: 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. Failure to follow the recommended inspection intervals provided in the IFU may result in serious patient injury.

Recalling firm: The Anspach Effort, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2022-12-07
Firm location: Palm Beach Gardens, FL, United States

510(k) clearances named in this recall

2 on FDA's record

K133604 — ANSPACH EG1 HIGH SPEED SYSTEM, G1 ATTACHMENTSThe Anspach Effort, Inc.·cleared 2014-01-10
K011444 — ANSPACH EMAX DRILL SYSTEMThe Anspach Effort, Inc.·cleared 2001-08-08

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

6.5 cm Adult Rotating Craniotome Attachment. Use with XMax¿, microMax, and eMax¿ Systems. Ref: CRANI-A Intended for cutting and shaping bone including the spine and cranium

Reason for recall

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. Failure to follow the recommended inspection intervals provided in the IFU may result in serious patient injury

Data sourced from openFDA. This site is unofficial and independent of the FDA.