Z-1684-2016 Class II Terminated
FDA device recall Z-1684-2016 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: 3893.
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
- 3893
Product Description
Trilogy self-tapping bone screw Bone screw 4.5x25 selftap 00625004525 Bone screw 4.5x50 selftap 00625004550 Bone screw 6.5x15 selftap 00625006515 Bone screw 6.5x20 selftap 00625006520 Bone screw 6.5x25 selftap 00625006525 Bone screw 6.5x30 selftap 00625006530
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
LOTS: 63284570 63284572 63284573 63187350 63225662 63272712 63296123 63301504 63204283 63209528 63259476 63257719