Skip to content
Recall Observatory FDA recall evidence

Device product

Herbert Cannulated Bone Screw System, Bone Screw, 6.5 mm Dia., 45 mm Length 47115504507 Herbert Cannulated Bone Screw System, Bone Screw, 6.5 mm Dia., 75 mm Length 47115507507 Herbert Cannulated Bone Screw System, Bone Screw, 6.5 mm Dia., 90 mm Length 47115509007

Z-1680-2016

May 04, 2016

Class II

Product summary

Firm
Zimmer Manufacturing B.V.
Event
Event 73981
Status
Terminated
Classification
Class II
Quantity
90
Official record key
device-enforcement:Z-1680-2016

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: 63303808 63292589 63292588

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.