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Recall Observatory FDA recall evidence

Device product

VersaFx Femoral Fixation System Hex head compression screw 4.7 mm dia. 2 inch (51 mm) length 47116202400

Z-1682-2016

May 04, 2016

Class II

Product summary

Firm
Zimmer Manufacturing B.V.
Event
Event 73981
Status
Terminated
Classification
Class II
Quantity
50
Official record key
device-enforcement:Z-1682-2016

Official wording

Reason: A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws.

Code information: LOT: 63290189

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws.