Zimmer Recalls VerSys Provisional Femoral Heads Due to Fit Issues
Zimmer, Inc. is recalling VerSys provisional femoral heads because they may fit too loosely or too tightly with mating components, posing a risk of intraoperative dislodging.
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 being left in-vivo, which aligns with the 'Severe' rubric criteria for Class II recalls with significant injury reports.
Plain-English summary
Zimmer, Inc. is recalling VerSys provisional femoral heads, including specific 32mm sizes and 12/14 neck tapers. The recall covers 231,641 units across all lots and sizes, distributed worldwide to the United States, Canada, Mexico, South America, Europe, Puerto Rico, China, and Korea. These devices are used during total hip arthroplasty to trial range of motion and determine appropriate implant size.
The recall was initiated after complaints reported 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 too tight. This improper fit has led to intraoperative dislodging of the provisional head and instances where the head was left in the patient's body after separating from the mating component.
Healthcare providers and patients should contact Zimmer, Inc. for instructions on how to handle the affected devices. The source text does not specify a particular action for consumers, but the recall is directed at the medical supply chain and surgical settings where these provisional implants are utilized.
The recalled product
- Product
- 12/14 Neck Taper 00789503201 VerSys Femoral Head Provisional 32mm -3.5 00789503202 VerSys Femoral Head Provisional 32mm +0 00789503203 VerSys Femoral Head Provisional 32mm +3.5 00789503204 VerSys Femoral Head Provisional 32mm +7 00789503205 VerSys Femoral Head Provisional…
- 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 distributed from lot 69998600 (2/20/1996) 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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