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Recall Observatory FDA recall evidence

Device product

Product 61 consists of all product under product code: JWH and same usage: Item no: 598003712 STD PRECOAT TIBIA PLATE S for use in total knee arthroplasty

Z-1159-2016

January 11, 2016

Class II

Product summary

Firm
Zimmer Manufacturing B.V.
Event
Event 72900
Status
Terminated
Classification
Class II
Quantity
39
Official record key
device-enforcement:Z-1159-2016

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.: 61678240 61838251 61838252 61838253 61838254 61901158 61901159 61925016 61926797 61958844 61958845 61999206 61999207 62037903 62037904 62037905 62070148 62070149 62141260 62170961 62191179 62220224 62232384 62245104 62284609 62298550 62298551 62313021 62319305 62326309 62359946

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.