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Recall Observatory FDA recall evidence

Device product

00789502801 VerSys Femoral Head Provisional 28mm -3.5 00789502802 VerSys Femoral Head Provisional 28mm +0 00789502803 VerSys Femoral Head Provisional 28mm +3.5 00789502804 VerSys Femoral Head Provisional 28mm +7 00789502805 VerSys Femoral Head Provisional 28mm +10.5 12/14 Neck Taper The provisional heads replicate final femoral implant geometry and are used to trial range of motion, joint stability, and determine appropriate femoral head size and offset during total hip arthroplasty.

Z-2475-2012

April 01, 2011

Class II

Product summary

Firm
Zimmer, Inc.
Event
Event 62110
Status
Terminated
Classification
Class II
Quantity
231,641 all lots, all sizes
Official record key
device-enforcement:Z-2475-2012

Official wording

Reason: Complaints have been received reporting sub-optimal fit between provisional femoral heads (VerSys and MIS) and the mating components (ie stems and provisional femoral necks), in some cases alleging the fit was too loose and in other cases, alleging the fit was too tight. Intraoperative dislodging of the provisional head and the provisional head being left in-vivo after separating from mating comp

Code information: All lots distributed from lot 69998600 (2/20/1996) to present

Distribution pattern: Worldwide Distribution - USA (nationwide) and internationally to Canada, Mexico, South America, Europe, Puerto Rico, China, and Korea.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Complaints have been received reporting sub-optimal fit between provisional femoral heads (VerSys and MIS) and the mating components (ie stems and provisional femoral necks), in some cases alleging the fit was too loose and in other cases, alleging the fit was too tight. Intraoperative dislodging of the provisional head and the provisional head being left in-vivo after separating from mating comp