Medacta Recalls Versafitcup Impacting Rings for Fit Issues
Medacta USA is recalling Versafitcup Impacting Rings because they may not fit properly in the implant shell, potentially causing surgical delays and complications.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device where a defect could lead to surgical complications and increased risk under anesthesia, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Medacta USA is recalling 293 units of Versafitcup Impacting Rings, model numbers 01.26.10.0133 through 01.26.10.0142, due to a potential fit issue. The impaction ring may not fit properly in the implant shell in all cases. These devices are designed for cementless use in total hip arthroplasty.
The recall is being conducted because the improper fit could result in surgical delays, potentially increasing possible complications under anesthesia. It may also require reaming up to a larger shell size, leaving less bone than planned, or repositioning/removal of the shell after initial impaction.
The affected units were distributed nationwide, including in Idaho, Colorado, Texas, Wisconsin, New York, Connecticut, Washington, California, Utah, and Arizona. Healthcare providers should stop using the affected lots and contact Medacta USA for instructions on return or replacement.
The recalled product
- Product
- Versafitcup Impacting Ring Model Number: 01.26.10.0133 (46mm), 01.26.10.0134 (48mm), 01.26.10.0135 (50mm), 01.26.10.0136 (52mm), 01.26.10.0137 (54mm), 01.26.10.0138 (56mm), 01.26.10.0139 (58mm), 01.26.10.0140 (60mm), 01.26.10.0141 (62mm), 01.26.10.0142 (64mm). Designed for…
- Manufacturer
- Medacta Usa Inc
- Affected units
- 293
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 (20)
- Reference Number Lot Number Reference Number Lot Number 01.26.10.0133: 095920
- 096050
- 096050A
- 01.26.10.0138: 095925
- 096055
- 096055A
- 01.26.10.0134: 095921
- 096051
- 096051A
- 01.26.10.0139: 095926
- 096056
- 096056A
- 01.26.10.0135: 095922
- 096052
- 096052A
- 01.26.10.0140: 095927
- 096057
- 096057A
- 01.26.10.0136: 095923
- 096053
Distribution
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