Z-0630-2019 Class II Terminated
FDA device recall Z-0630-2019 was initiated by Zimmer Biomet, Inc. on Oct 31, 2018 and is designated Class II. Reason for recall: Screw is missing from the package The recall status is terminated (terminated Apr 8, 2019). Affected quantity: 19 units.
Recall Details
- Product Type
- Devices
- Report Date
- Dec 26, 2018
- Initiation Date
- Oct 31, 2018
- Termination Date
- Apr 8, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 19 units
Product Description
NexGen¿ Complete Knee Solution Femoral Augment Block Distal only, 15mm, Size E with Screw Item Number: 00599003523 NexGen Distal Femoral Augment Block is used when femoral components can neither be downsized nor can be distally augmented by increasing the thickness of the cement mantle.
Reason for Recall
Screw is missing from the package
Distribution Pattern
Worldwide Distribution: US (nationwide) to states of: OH, FL, NJ, NY, OH, PA, TX, WV and to countries of: CANADA, AUSTRALIA, JAPAN, GERMANY, and NETHERLANDS.
Code Information
Lot Number: 62925336 UDI Number: (01)00889024224131(17)250228(10)62925336
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0630-2019
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026