Z-0617-2018 Class II Terminated
FDA device recall Z-0617-2018 was initiated by Synthes USA on August 10, 2017 and is designated Class II. Reason for recall: The contract supplier notified DePuy Synthes on June 16, 2017 that the kit expiration dates do not align with the earliest expiration date of the component lots within the kit. Some kit expiration dat… The recall status is terminated (terminated September 10, 2018). Affected quantity: 239 units.
Recall Details
- Product Type
- Devices
- Report Date
- February 21, 2018
- Initiation Date
- August 10, 2017
- Termination Date
- September 10, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 239 units
Product Description
Norian Drillable Inject
Reason for Recall
The contract supplier notified DePuy Synthes on June 16, 2017 that the kit expiration dates do not align with the earliest expiration date of the component lots within the kit. Some kit expiration dates were later than the earliest expiration date of the component lots. The expiration dates of some components are earlier than that listed on the kit.
Distribution Pattern
Nationwide Distribution.
Code Information
Product Number: 07.704.003S Lot Number: DSD9110