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Recall Observatory FDA recall evidence

Device product

ITST intertrochanteric/subtrochanteric fixation 4.5 mm diameter cortical screw, 3.5 mm hex head, 57 mm length 00225305745

Z-1681-2016

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-1681-2016

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: 63275969

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.