Recall Z-2479-2012
Zimmer, Inc. · initiated April 1, 2011
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
00780302201 MIS 12/14 Slotted Femoral Head Provisional -2X22 00780302202 MIS 12/14 Slotted Femoral Head Provisional +0X22 00780302203 MIS 12/14 Slotted Femoral Head Provisional +3.5X22 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.
Codes / lots: All lots including lot 78939000 (1/7/2002) to present
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
FDA-determined cause: Device Design
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.
Details
- Recall number
- Z-2479-2012
- Initiated
- April 1, 2011
- Posted by FDA
- September 28, 2012
- Terminated
- May 16, 2014
- Product code
- HWT – Template
- Quantity
- 231, 641 all lots
- Distribution
- Worldwide Distribution - USA (nationwide) and internationally to Canada, Mexico, South America, Europe, Puerto Rico, China, and Korea.
- Recalling firm
- Zimmer, Inc., Warsaw, IN
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2473-2012 Class II | 00789502202 VerSys Femoral Head Provisional 22mm +0 00789502203 VerSys Femoral Head…Complaints have been received reporting sub-optimal fit between provisional femoral heads (VerSys and MIS)… | 04/01/2011Terminated |
| Z-2474-2012 Class II | 00789502601 VerSys Femoral Head Provisional 26mm -3.5 00789502602 VerSys Femoral Head…Complaints have been received reporting sub-optimal fit between provisional femoral heads (VerSys and MIS)… | 04/01/2011Terminated |
| Z-2475-2012 Class II | 00789502801 VerSys Femoral Head Provisional 28mm -3.5 00789502802 VerSys Femoral Head…Complaints have been received reporting sub-optimal fit between provisional femoral heads (VerSys and MIS)… | 04/01/2011Terminated |
| Z-2476-2012 Class II | 12/14 Neck Taper 00789503201 VerSys Femoral Head Provisional 32mm -3.5 00789503202…Complaints have been received reporting sub-optimal fit between provisional femoral heads (VerSys and MIS)… | 04/01/2011Terminated |
| Z-2477-2012 Class II | 00789503601 VerSys Femoral Head Provisional 36mm -3.5 00789503602 VerSys Femoral Head…Complaints have been received reporting sub-optimal fit between provisional femoral heads (VerSys and MIS)… | 04/01/2011Terminated |
| Z-2478-2012 Class II | 12/14 Neck Taper 00789504001 VerSys Femoral Head Provisional 40mm -3.5 00789504002…Complaints have been received reporting sub-optimal fit between provisional femoral heads (VerSys and MIS)… | 04/01/2011Terminated |
| Z-2480-2012 Class II | 00780302601 MIS 12/14 Slotted Femoral Head Provisional -3.5X26 00780302602 MIS 12/14…Complaints have been received reporting sub-optimal fit between provisional femoral heads (VerSys and MIS)… | 04/01/2011Terminated |
| Z-2481-2012 Class II | 00780302801 MIS 12/14 Slotted Femoral Head Provisional -3.5X28 00780302802 MIS 12/14…Complaints have been received reporting sub-optimal fit between provisional femoral heads (VerSys and MIS)… | 04/01/2011Terminated |
| Z-2482-2012 Class II | 00780303201 MIS 12/14 Slotted Femoral Head Provisional -3.5X32 00780303202 MIS 12/14…Complaints have been received reporting sub-optimal fit between provisional femoral heads (VerSys and MIS)… | 04/01/2011Terminated |
| Z-2483-2012 Class II | 00780303601 MIS 12/14 Slotted Femoral Head Provisional -3.5X36 00780303602 MIS 12/14…Complaints have been received reporting sub-optimal fit between provisional femoral heads (VerSys and MIS)… | 04/01/2011Terminated |
| Z-2484-2012 Class II | 00780304001 MIS 12/14 Slotted Femoral Head Provisional -3.5X36 00780304002 MIS 12/14…Complaints have been received reporting sub-optimal fit between provisional femoral heads (VerSys and MIS)… | 04/01/2011Terminated |