Howmedica Recalls Accolade and Restoration Hip Products Due to Sealing Defect
Howmedica Osteonics Corp. is recalling 255 Accolade and Restoration hip products because the inner and outer sterile barriers were not fully sealed.
What this means for you
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, but the source text does not report any hospitalizations, injuries, or illnesses. The hazard is a packaging defect (unsealed sterile barriers) without reported adverse health consequences, fitting the criteria for a moderate severity score.
Plain-English summary
Howmedica Osteonics Corp. is recalling 255 units of the Accolade and Restoration hip product. The recall is due to a defect where the inner and outer sterile barriers were not fully sealed.
The affected products include catalog numbers 6021-0030, 6276-1-127, 6276-5-216, 6020-2530, 6020-4535, 6021-0740, 6021-0230, and 6021-4535. The specific lot numbers involved are 55624702, 55709001, 55709002, 55709003, 55959003, 55967305, 56011203, 56011205, 56011301, 56019501, and 56109304.
These products were distributed in ten U.S. states (AR, DE, FL, IL, IN, MI, NJ, OH, TN, and TX) as well as in Canada, Sweden, the United Kingdom, France, Spain, Italy, Japan, Romania, Colombia, the Netherlands, and Australia. The source text does not specify instructions for consumers or healthcare providers regarding the next steps for this recall.
The recalled product
- Product
- Accolade and Restoration hip product; Catalog Number: 6021-0030, 6276-1-127, 6276-5-216, 6020-2530, 6020-4535, 6021-0740, 6021-0230, and 6021-4535
- Manufacturer
- Howmedica Osteonics Corp.
- 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 (11)
- Lot: 55624702
- 55709001
- 55709002
- 55709003
- 55959003
- 55967305
- 56011203
- 56011205
- 56011301
- 56019501
- and 56109304
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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