Z-2478-2012 Class II Terminated
FDA device recall Z-2478-2012 was initiated by Zimmer, Inc. on Apr 1, 2011 and is designated Class II. 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 recall status is terminated (terminated May 16, 2014). Affected quantity: 231,641.
Recall Details
- Product Type
- Devices
- Report Date
- Oct 10, 2012
- Initiation Date
- Apr 1, 2011
- Termination Date
- May 16, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 231,641
Product Description
12/14 Neck Taper 00789504001 VerSys Femoral Head Provisional 40mm -3.5 00789504002 VerSys Femoral Head Provisional 40mm +0 00789504003 VerSys Femoral Head Provisional 40mm +3.5 00789504004 VerSys Femoral Head Provisional 40mm +7 00789504005 VerSys Femoral Head Provisional 40mm +10.5 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.
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
Distribution Pattern
Worldwide Distribution - USA (nationwide) and internationally to Canada, Mexico, South America, Europe, Puerto Rico, China, and Korea.
Code Information
All lots distributed from lot 69998600 (2/20/1996) to present
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2478-2012
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026