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Recall Observatory FDA recall evidence

Device product

Product 11 consists of all product under product code JDI , and same usage: Item no: 902602500 6 DEGREE COCR FEM HEAD 26 902602600 6 DEGREE COCR FEM HEAD 26 902602700 6 DEGREE COCR FEM HEAD 26 902602800 6 DEGREE COCR FEM HEAD 28 902602900 6 DEGREE COCR FEM HEAD 28 902603000 6 DEGREE COCR FEM HEAD 28 902603300 6 DEGREE COCR FEM HEAD 32 902603200 6 DEGREE COCR FEM HEAD 32 Product Usage: For use in total or hemi hip arthroplasty

Z-1109-2016

January 11, 2016

Class II

Product summary

Firm
Zimmer Manufacturing B.V.
Event
Event 72900
Status
Terminated
Classification
Class II
Quantity
366
Official record key
device-enforcement:Z-1109-2016

Official wording

Reason: As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.

Code information: lot no:61603870 60973105N 60892289N 60900891N 62279763 62093449 62185961 62279764 62384218 62082438 62268537 62384219

Distribution pattern: US Nationwide Distribution

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.