Z-1008-2018 Class II Terminated
FDA device recall Z-1008-2018 was initiated by Zimmer Biomet, Inc. on September 15, 2017 and is designated Class II. Reason for recall: One piece from a different lot mixed with lot 236840 and is incorrectly etched as -6MM offset instead of +3MM offset. As the incorrect etching and related size difference affects the functional use of… The recall status is terminated (terminated August 20, 2018). Affected quantity: 23.
Recall Details
- Product Type
- Devices
- Report Date
- March 21, 2018
- Initiation Date
- September 15, 2017
- Termination Date
- August 20, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 23
Product Description
36MM COCR MODULAR HD -6MM
Reason for Recall
One piece from a different lot mixed with lot 236840 and is incorrectly etched as -6MM offset instead of +3MM offset. As the incorrect etching and related size difference affects the functional use of this product, the affected lot is being removed from the field.
Distribution Pattern
Outside USA
Code Information
11-363660 UDI Number: (01) 00880304210509 (17) 270507 (10) 236840 Product Number: 11-363660 Lot Number: 236840