Z-1675-2016 Class II Terminated
FDA device recall Z-1675-2016 was initiated by Zimmer Manufacturing B.V. on May 4, 2016 and is designated Class II. Reason for recall: A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws. The recall status is terminated (terminated July 5, 2017). Affected quantity: 200.
Recall Details
- Product Type
- Devices
- Report Date
- May 25, 2016
- Initiation Date
- May 4, 2016
- Termination Date
- July 5, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 200
Product Description
Zimmer universal locking system (ULS) 3.5 mm cortical screw selftapping 18 mm length 47493501801
Reason for Recall
A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws.
Distribution Pattern
Worldwide distribution. US nationwide, Korea, Japan, Argentina, Brazil, Singapore, Taiwan, China, El Salvador, Australia, India, Hong Kong, Chile, Germany, Italy, France, Spain, UK, Sweden, Canada.
Code Information
LOT: 63297474