Home / Recalls / The Anspach Effort, Inc. / Z-1979-2017

Z-1979-2017 Class II Terminated

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

Recall Details

Product Type
Devices
Report Date
May 10, 2017
Initiation Date
October 6, 2016
Termination Date
July 26, 2019
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
5

Product Description

B-SAGITTAL ASSEMBLY Product Usage: Pneumatic 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 serial numbers shipped to customers prior to 09/27/2016; DFU 18-0062; Part No. B-SAGITTAL.

Other recalls by The Anspach Effort, Inc.

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