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.
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 significant injury reports, specifically the intraoperative dislodging of the device and the provisional head being left in-vivo.
Plain-English summary
Zimmer, Inc. is recalling VerSys Femoral Head Provisional 26mm devices (catalog numbers 00789502601 through 00789502605) and MIS provisional femoral heads. The recall covers 231,641 units across all lots distributed from lot 69998600 (February 20, 1996) to the present. These 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 due to complaints reporting sub-optimal fit between the provisional femoral heads and mating components, such as stems and provisional femoral necks. Some reports alleged the fit was too loose, while others alleged it was too tight. This improper fit has resulted in intraoperative dislodging of the provisional head and instances where the provisional head was left in the patient's body after separating from the mating component.
The affected devices were distributed worldwide, including nationwide in the United States and internationally to Canada, Mexico, South America, Europe, Puerto Rico, China, and Korea. Healthcare providers should stop using these devices and contact Zimmer, Inc. for further instructions on the recall.
The recalled product
- Product
- 00789502601 VerSys Femoral Head Provisional 26mm -3.5 00789502602 VerSys Femoral Head Provisional 26mm +0 00789502603 VerSys Femoral Head Provisional 26mm +3.5 00789502604 VerSys Femoral Head Provisional 26mm +7 00789502605 VerSys Femoral Head Provisional 26mm +10.5 12/14 Ne
- Manufacturer
- Zimmer, Inc.
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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