Encore Medical Recalls Mislabelled 6.5 mm Cancellous Bone Screws
Encore Medical is recalling 18 bone screws because the package label incorrectly states the size is 30mm, while the actual screw dimension is 25mm.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves a labeling error where the stated size (30mm) differs from the actual size (25mm). This fits the rubric for minor labeling errors or low-risk contamination, as no injuries or illnesses are reported.
Plain-English summary
Encore Medical, Lp is recalling one lot of 6.5 mm Cancellous Bone Screws. The recall was initiated after a product complaint identified a mislabeling error on the devices. The product is intended for the fixation of the acetabular shell or fracture repair.
The specific issue is that the package label indicates the screw size is 30mm, but the actual screw dimension is 25mm. The recalled product is identified by Lot 007A1037 and Reference 010-55-25. A total of 18 devices were distributed nationwide, including to facilities in Arkansas, California, Florida, Idaho, Oklahoma, Pennsylvania, Texas, and Utah.
Healthcare providers and facilities that have received these devices should stop using them and contact Encore Medical, Lp for further instructions regarding the return or replacement of the mislabelled screws.
The recalled product
- Product
- djo surgical Screw 6.5 mm, Sz 25mm, low profile. Product is intended for the fixation of the acetabular shell or fracture repair
- Manufacturer
- Encore Medical, Lp
- Hazard
- Affected units
- 18
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)
- Lot 007A1037
- Ref 010-55-25.
Distribution
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