Non-Sterile Double Ended Trial Kit, Small Footprint, (6110-N01-KTS01) for the Cervical Cage. The kit includes 3 trials. Orthopedic manual surgical instrument
Reported: May 11, 2022 Initiated: March 30, 2022 #Z-1026-2022
Product Description
Non-Sterile Double Ended Trial Kit, Small Footprint, (6110-N01-KTS01) for the Cervical Cage. The kit includes 3 trials. Orthopedic manual surgical instrument
Reason for Recall
Product labeled incorrectly. The lot was labeled with Small footprint when the product was Medium.
Details
- Recalling Firm
- restor3d Inc.
- Units Affected
- 14 units
- Distribution
- US Nationwide distribution in the states of KY, NC, NJ, TX, IN, VA and AL.
- Location
- Durham, NC
Frequently Asked Questions
What product was recalled? ▼
Non-Sterile Double Ended Trial Kit, Small Footprint, (6110-N01-KTS01) for the Cervical Cage. The kit includes 3 trials. Orthopedic manual surgical instrument. Recalled by restor3d Inc.. Units affected: 14 units.
Why was this product recalled? ▼
Product labeled incorrectly. The lot was labeled with Small footprint when the product was Medium.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 11, 2022. Severity: Moderate. Recall number: Z-1026-2022.
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