Recall Z-0917-2023— The Anspach Effort, Inc.

Name: FDA recall Z-0917-2023
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 Craniotome, Thin Foot Plate Attachment. Use with XMax¿, microMax, and eMax¿ Systems Ref: CRANI-A-01 intended for cutting and shaping bone including the spine and cranium by trained medical/surgical personnel. 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 Craniotome, Thin Foot Plate Attachment. Use with XMax¿, microMax, and eMax¿ Systems Ref: CRANI-A-01 intended for cutting and shaping bone including the spine and cranium by trained medical/surgical personnel

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.