Zimmer Recalls Provisional Femoral Heads Due to Fit Issues
Zimmer, Inc. is recalling provisional femoral heads used in hip surgery due to reports of sub-optimal fit with mating components.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves reports of significant injury, specifically the intraoperative dislodging of the device and the device being left in-vivo, which aligns with the 'Severe' criteria for significant injury reports.
Plain-English summary
Zimmer, Inc. is recalling specific lots of MIS 12/14 Slotted Femoral Head Provisional devices. These medical devices are used during total hip arthroplasty to trial range of motion, joint stability, and determine appropriate femoral head size and offset. The recall covers 231,641 units across all lots and sizes, distributed worldwide including the United States, Canada, Mexico, South America, Europe, Puerto Rico, China, and Korea.
The recall was initiated after complaints were received reporting sub-optimal fit between the provisional femoral heads and their mating components, such as stems and provisional femoral necks. Some reports alleged the fit was too loose, while others alleged it was too tight. In some cases, this resulted in the intraoperative dislodging of the provisional head or the head being left in the body after separating from the mating component.
Healthcare providers and patients should contact Zimmer, Inc. for further instructions regarding the return or replacement of these devices. The recall is classified as Class II by the FDA, indicating a reasonable probability of temporary or medically reversible adverse health consequences.
The recalled product
- Product
- 00780304001 MIS 12/14 Slotted Femoral Head Provisional -3.5X36 00780304002 MIS 12/14 Slotted Femoral Head Provisional +0X36 00780304003 MIS 12/14 Slotted Femoral Head Provisional +3.5X36 00780304004 MIS 12/14 Slotted Femoral Head Provisional +7X36 00780304005 MIS 12/14 Slotte
- Manufacturer
- Zimmer, Inc.
- Hazard
- Affected units
- 231,641
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All lots including lot 78939000 (1/7/2002) to present
Distribution
Part of a larger recall action
This product is one of 12 recalled by Zimmer, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 12 products in this recall →Related recalls
Same manufacturer · Zimmer, Inc.
See all →- HighZimmer Off-Axis Alliance Glenoid Reamer Guide recalled for breakage
FDA (Devices) · 2026-07-01
- ModerateZimmer Shoulder System Reamer Guide recalled for plastic breakage
FDA (Devices) · 2026-07-01
- ModeratePersona Revision Trabecular Metal Femoral Distal Augment recalled for packaging defect
FDA (Devices) · 2026-07-01
- HighZimmer Shoulder Reamer Guide System Recalled for Plastic Breakage
FDA (Devices) · 2026-07-01
- HighZimmer Off-Axis Alliance Glenoid Reamer Guide Plastic Breakage Recall
FDA (Devices) · 2026-07-01
Same hazard · device malfunction
See all →- HighPhilips Incisive CT Recalled for Potential Failure to Trigger Clinical Scan
FDA (Devices) · 2026-09-02
- HighBD Needle Kit for Powered Driver Recall Due to Removal Difficulty
FDA (Devices) · 2026-08-26
- HighBoston Scientific Recalls Suture Cinch Endoscopic Tissue Approximation Devices
FDA (Devices) · 2026-08-26
- HighIntegrated Medcraft Recalls First Aid Kits with Defective Airway Tips
FDA (Devices) · 2026-08-12
- SevereStryker AHTO Tube Set Packaging Recalled for Handpiece Leaking
FDA (Devices) · 2026-08-12