Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
00780302601 MIS 12/14 Slotted Femoral Head Provisional -3.5X26 00780302602 MIS Recalled by Zimmer, Inc. Due to Complaints have been received reporting sub-optimal fit between...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Zimmer, Inc. directly.
Affected Products
00780302601 MIS 12/14 Slotted Femoral Head Provisional -3.5X26 00780302602 MIS 12/14 Slotted Femoral Head Provisional +0X26 00780302603 MIS 12/14 Slotted Femoral Head Provisional +3.5X26 00780302604 MIS 12/14 Slotted Femoral Head Provisional +7X26 00780302605 MIS 12/14 Slotted Femoral Head Provisional +10.5X26 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.
Quantity: 231,641
Why Was This 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
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Zimmer, Inc.
Zimmer, Inc. has 437 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report