Home / Recalls / The Anspach Effort, Inc. / Z-1950-2017

Z-1950-2017 Class II Terminated

Recalled by The Anspach Effort, Inc. — Palm Beach Gardens, FL

FDA device recall Z-1950-2017 was initiated by The Anspach Effort, Inc. on Oct 6, 2016 and is designated Class II. Reason for recall: Supplied Directions for Use (DFU) did not contain a recommended service interval. The recall status is terminated (terminated Jul 26, 2019). Affected quantity: 158.

Recall Details

Product Type: Devices
Report Date: May 10, 2017
Initiation Date: Oct 6, 2016
Termination Date: Jul 26, 2019
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 158

Product Description

eMax2 Motor Assembly Product Usage: Electric system

Reason for Recall

Supplied Directions for Use (DFU) did not contain a recommended service interval.

Distribution Pattern

Worldwide Distribution - US Nationwide in the states of HI, DC including PR and the countries of Guam and Japan

Code Information

All product shipped prior to 09/27/2016; DFU 18-0085; Part No. eMax2.

Source

Dataset: openFDA device recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for Z-1950-2017
openFDA file date: Oct 23, 2026
Loaded by RegDataLab: Oct 26, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

Other recalls by The Anspach Effort, Inc.

Z-0921-2023 Class II — Adult Craniotome, Large Ref: CRANI-L-G1 Intended for cutting and shaping… (Dec 7, 2022)
Z-0916-2023 Class II — 6.5 cm Adult Rotating Craniotome Attachment. Use with XMax¿, microMax, and eMax¿… (Dec 7, 2022)
Z-0918-2023 Class II — Adult Craniotome Ref: CRANI-A-G1 Intended for cutting and shaping bone… (Dec 7, 2022)
Z-0917-2023 Class II — 6.5 cm Adult Craniotome, Thin Foot Plate Attachment. Use with XMax¿, microMax… (Dec 7, 2022)
Z-0924-2023 Class II — Pediatric Craniotome Ref:CRANI-P-G1 (Dec 7, 2022)
Z-0919-2023 Class II — 6.5 cm Adult Rotating Craniotome Attachment. Use with XMax¿, microMax, and eMax¿… (Dec 7, 2022)
Z-0923-2023 Class II — 6.5 cm Pediatric Craniotome Attachment. Use with XMax¿, microMax, and eMax¿… (Dec 7, 2022)
Z-0920-2023 Class II — 7.5 cm Large Craniotome Attachment Use with XMax¿, microMax, and eMax¿ Systems… (Dec 7, 2022)
Z-0922-2023 Class II — 7.5 cm Large Rotating Craniotome Attachment. Use with XMax¿, microMax, and eMax¿… (Dec 7, 2022)
Z-0398-2018 Class II — OSCILLATING SAW ATTACHMENT Surgical instrument motors and… (Sep 29, 2017)