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Recall Observatory FDA recall evidence

Device product

Product 34 consists of all product under product code: JWH and same usage: Item no: 522001700 I/B II KNEE DOMED PATELLA 522001800 I/B II KNEE DOMED PATELLA 522001900 I/B II KNEE DOMED PATELLA for use in total knee arthroplasty

Z-1132-2016

January 11, 2016

Class II

Product summary

Firm
Zimmer Manufacturing B.V.
Event
Event 72900
Status
Terminated
Classification
Class II
Quantity
512
Official record key
device-enforcement:Z-1132-2016

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.: 61932449 62126613 62204611 62213348 62406239 62203954 62204587 62332733 62236654 62406245

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.