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Recall Observatory FDA recall evidence

Device product

Zimmer Plates and Screws (ZPS) 3.5 mm Cortical Screw SelfTapping, 10 mm Length 47483501001 3.5 mm Cortical Screw SelfTapping, 14 mm Length 47483501401 3.5 mm Cortical Screw SelfTapping, 16 mm Length 47483501601 3.5 mm Cortical Screw SelfTapping, 24 mm Length 47483502401 3.5 mm Cortical Screw SelfTapping, 30 mm Length 47483503001 3.5 mm Cortical Screw SelfTapping, 40 mm Length 47483504001 3.5 mm Cortical Screw SelfTapping, 75 mm Length 47483507501

Z-1673-2016

May 04, 2016

Class II

Product summary

Firm
Zimmer Manufacturing B.V.
Event
Event 73981
Status
Terminated
Classification
Class II
Quantity
794
Official record key
device-enforcement:Z-1673-2016

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: LOTS: 63252354 63283819 63308551 63252355 63312340 63252350 63283820 63243831

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.