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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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 significant injury reports, specifically intraoperative dislodging and devices left in-vivo, which meets the criteria for a Severe rating.
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 was initiated after complaints were received reporting sub-optimal fit between the provisional femoral heads and mating components, such as stems and provisional femoral necks. In some cases, the fit was alleged to be too loose, while in others, it was alleged to be too tight. These fit issues have resulted in intraoperative dislodging of the provisional head and instances where the provisional head was left in the body after separating from the mating component.
The recall affects 231,641 units distributed worldwide, including the United States, Canada, Mexico, South America, Europe, Puerto Rico, China, and Korea. Healthcare providers should stop using these devices and contact Zimmer, Inc. for further instructions.
The recalled product
- Product
- 00780303201 MIS 12/14 Slotted Femoral Head Provisional -3.5X32 00780303202 MIS 12/14 Slotted Femoral Head Provisional +0X32 00780303203 MIS 12/14 Slotted Femoral Head Provisional +3.5X32 00780303204 MIS 12/14 Slotted Femoral Head Provisional +7X32 00780303205 MIS 12/14…
- Manufacturer
- Zimmer, Inc.
- 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.
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