Recall Z-0882-2017— Amendia, Inc
Class II · Terminated
Class II FDA medical device recall by Amendia, Inc, initiated 2016-11-22, terminated 2024-02-01. FDA's recall record names no specific 510(k) clearance for this event. Product: Dual Stylet Needle, Part Number 812-11R-15 The guide wire is passed through the cannulated handle of the Dual Stylet Needles and pressed into the bone. Reason: The rods are packaged in packages with unacceptable seals. In some cases, the integrity of the seal is compromised by channels or voids..
- Recalling firm
- Amendia, Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-11-22
- Terminated
- 2024-02-01
- Firm location
- Marietta, GA, United States
Product description
Dual Stylet Needle, Part Number 812-11R-15 The guide wire is passed through the cannulated handle of the Dual Stylet Needles and pressed into the bone
Reason for recall
The rods are packaged in packages with unacceptable seals. In some cases, the integrity of the seal is compromised by channels or voids.
Data sourced from openFDA. This site is unofficial and independent of the FDA.