Pediatric Craniotome
Reported: May 10, 2017 Initiated: October 6, 2016 #Z-1991-2017
Product Description
Pediatric Craniotome
Reason for Recall
Supplied Directions for Use (DFU) did not contain a recommended service interval.
Details
- Recalling Firm
- The Anspach Effort, Inc.
- Units Affected
- 679
- 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? ▼
Pediatric Craniotome. Recalled by The Anspach Effort, Inc.. Units affected: 679.
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-1991-2017.
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