—#112439

Product

00780302801 MIS 12/14 Slotted Femoral Head Provisional -3.5X28 00780302802 MIS 12/14 Slotted Femoral Head Provisional +0X28 00780302803 MIS 12/14 Slotted Femoral Head Provisional +3.5X28 00780302804 MIS 12/14 Slotted Femoral Head Provisional +7X28 00780302805 MIS 12/14 Slotted Femoral Head Provisional +10.5X28 00780302814 MIS 12/14 Slotted Femoral Head Provisional +7X28 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.

FDA product code: HWT — Template
Device class: Class 1
Medical specialty: Orthopedic
Affected lot / code info: All lots including lot 78939000 (1/7/2002) to present

Why it was recalled

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

Root cause (FDA determination)

Device Design

Action the firm took

Zimmer, Inc. sent an E-mail letter dated April 21, 2011, to all affected customers in the US. A June 2011 E-mail was sent to all customers outside the US. The letters requested Inventory & Operations Managers to check product for proper fit /function, complete the return form with worn provisional heads to Zimmer Inc, Attention Product Service, 1777 West Center St. Warsaw, IN 46580. For questions regarding this recall call 574-372-4753.

Recalling firm

Firm: Zimmer, Inc.
Address: 345 E Main St, Warsaw, Indiana 46580-2746

Distribution

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

Timeline

Recall initiated: 2011-04-01
Posted by FDA: 2012-09-28
Terminated: 2014-05-16
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #112439. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.