Encore Medical Recalls 6.5mm Cancellous Bone Screws Due to Labeling Errors
Encore Medical is recalling 6.5mm Cancellous Bone Screws because some units were mislabeled with incorrect sizes, posing a risk of improper surgical fixation.
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 is classified as FDA Class II, and the hazard involves a risk-of-harm product (incorrect surgical implant size) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Encore Medical, Lp is recalling 6.5mm Cancellous Bone Screws, Model Number 10-55-025, Lot Number 006A1057. These medical devices are intended for the fixation of the acetabular shell or fracture repair. The recall was initiated after a product complaint revealed that a size 20 screw was labeled as size 30, though measurement confirmed it was actually a size 25. Further investigation found additional instances where screws were mislabeled, including a size 30 screw packaged with a size 25 label.
The distribution of these affected units was limited to California. While initial containment efforts suggested the issue was isolated to in-house inventory, subsequent determination indicated that some units may have been distributed. The primary hazard is the use of an incorrectly sized screw during surgery, which could lead to improper fixation of the acetabular shell or fracture repair.
Healthcare providers and patients who have used or possess these specific screws should contact Encore Medical, Lp for further instructions. The FDA has classified this as a Class II recall, indicating that use of the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
The recalled product
- Product
- 6.5mm Cancellous Bone Screw Intended to be used for the fixation of the acetabular shell or fracture repair.
- Manufacturer
- Encore Medical, Lp
- Affected units
- 1
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 (2)
- Model Number 10-55-025
- Lot Number 006A1057.
Distribution
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