STANDARD CRANIOTOME, BLACK MAX
Reported: May 10, 2017 Initiated: October 6, 2016 #Z-1962-2017
Product Description
STANDARD CRANIOTOME, BLACK MAX
Reason for Recall
Supplied Directions for Use (DFU) did not contain a recommended service interval.
Details
- Recalling Firm
- The Anspach Effort, Inc.
- Units Affected
- 148
- Distribution
- Worldwide Distribution - US Nationwide in the states of HI, DC including PR and the countries of Guam and Japan
- Location
- Palm Beach Gardens, FL
Frequently Asked Questions
What product was recalled? ▼
STANDARD CRANIOTOME, BLACK MAX. Recalled by The Anspach Effort, Inc.. Units affected: 148.
Why was this product recalled? ▼
Supplied Directions for Use (DFU) did not contain a recommended service interval.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 10, 2017. Severity: Moderate. Recall number: Z-1962-2017.
Related Recalls
FDA Devices Moderate
Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.2…
Vortex Surgical Inc. · 2026-02-11
FDA Devices Moderate
COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conju…
Beckman Coulter, Inc. · 2026-02-11
FDA Devices Moderate
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 Product Description: These inst…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330 Product Description: These in…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable Produc…
Fujirebio Diagnostics, Inc. · 2026-02-11