FDA Enforcement
Class II
Ongoing
DeRoyal CMC POSTERIOR SPINE PACK, REF 89-10570.01
Recall: Z-0692-2023
·
Reported December 21, 2022
Enforcement
- Recall Number
- Z-0692-2023
- Event ID
- 91134
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- DeRoyal Industries Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Report Date
- December 21, 2022
- Initiation Date
- November 3, 2022
- Classification Date
- December 15, 2022
- Address
- 200 Debusk Ln, N/A, Powell, TN, 37849-4703, United States
Description
DeRoyal CMC POSTERIOR SPINE PACK, REF 89-10570.01
Reason
XXX
Code Info
Lot Numbers: Lot 56190288 exp 8/1/2023; Lot 56224943 exp 8/1/2023; Lot 56432718 exp 2/1/2023; Lot 56432726 exp 8/1/2023; Lot 56639065 exp 8/1/2023; Lot 56906961 exp 8/1/2023; Lot 57051271 exp 8/1/2023; Lot 57228161 exp 8/1/2023; Lot 57393491 exp 1/1/2024; Lot 57488967 exp 3/1/2024; Lot 57679350 exp 3/1/2024; Lot 57685371 exp 3/1/2024; Lot 57751551 exp 3/1/2024
Distribution
US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi
Quantity
1196 kits