00780303201 MIS 12/14 Slotted Femoral Head Provisional -3.5X32 00780303202 MIS 12/14 Slotted Femoral Head Provisional +0

FDA device recall Z-2482-2012 · posted 2012-09-28 · Terminated

Recall details

Recalling firm

Zimmer, Inc.

Reason for recall

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

Action taken

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.

Root cause

Device Design

Status

Terminated

Product code

HWT

Quantity affected

231,641

Distribution

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

Date initiated

2011-04-01

Date posted

2012-09-28

Date terminated

2014-05-16

Location

Warsaw, IN