Howmedica Recalls Accolade and Restoration Hip Products Due to Barrier Defects
Howmedica Osteonics Corp. is recalling 255 Accolade and Restoration hip products because the inner and outer sterile barriers were not fully sealed.
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 the source text does not report any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Howmedica Osteonics Corp. is recalling 255 units of the Accolade and Restoration hip product, identified by catalog numbers 6720-0837 and 6721-0737. The recall is being conducted because the inner and outer sterile barriers of the devices were not fully sealed.
The affected products were distributed in ten U.S. states: Arkansas, Delaware, Florida, Illinois, Indiana, Michigan, New Jersey, Ohio, Tennessee, and Texas. The products were also distributed in Canada, Sweden, the United Kingdom, France, Spain, Italy, Japan, Romania, Colombia, the Netherlands, and Australia. Specific lot numbers involved in this recall are 56211103, 56211401, 56211704, and 57284004.
Consumers and healthcare providers should contact Howmedica Osteonics Corp. for further information regarding the recall and potential replacement or repair of the affected devices.
The recalled product
- Product
- Accolade and Restoration hip product; Catalog Number: 6720-0837 and 6721-0737
- Manufacturer
- Howmedica Osteonics Corp.
- Hazard
- Affected units
- 255
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 (4)
- Lot: 56211103
- 56211401
- 56211704
- 57284004
Distribution
Part of a larger recall action
This product is one of 2 recalled by Howmedica Osteonics Corp. 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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