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.
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, 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.
See all 2 products in this recall →Related recalls
Same manufacturer · Howmedica Osteonics Corp.
See all →- SevereHowmedica Recalls Scorpio Patella Implants Due to Polyethylene Wear Risk
FDA (Devices) · 2026-09-23
- HighHowmedica Recalls Orthopaedic Implants Due to Potential UHMWPE Oxidation
FDA (Devices) · 2026-09-23
- SevereHowmedica Recalls Orthopaedic Implants Due to Potential UHMWPE Oxidation
FDA (Devices) · 2026-09-23
- HighHowmedica Recalls Orthopaedic Implant Components Due to Material Aging
FDA (Devices) · 2026-09-23
- HighHowmedica Recalls Scorpio Receded Metal Backed Patella Implants
FDA (Devices) · 2026-09-23
Same hazard · packaging defect
See all →- HighEmbosphere Microspheres Recalled Due to Packaging Sterility Concerns
FDA (Devices) · 2026-10-07
- ModerateAmneal Recalls Estradiol Gel Packets Due to Empty or Partially Full Containers
FDA (Drugs) · 2026-10-07
- HighCardinal Health Recalls Presource Convenience Kits Due to Seal Defects
FDA (Devices) · 2026-09-30
- ModerateAVID Medical Recalls Halyard IV Start Kits Due to Packaging Seal Issues
FDA (Devices) · 2026-09-30
- HighCardinal Health Recalls Presource Convenience Kits Due to Potential Seal Defects
FDA (Devices) · 2026-09-30
Similar recalls
- ModerateStryker Howmedica Hip Prosthesis Components Recalled for Seal Defects
FDA (Devices) · 2015-05-27
- HighHip Arthroplasty Surgical Instruments Recalled for Sterile Barrier Failure
FDA (Devices) · 2024-02-14
- HighHowmedica X3 Triathlon CS Insert Recalled for Packaging Defects
FDA (Devices) · 2024-03-13
- ModerateStryker Restoration Anatomic Shell Recall Due to Packaging Defect
FDA (Devices) · 2020-05-27
- ModerateStryker Restoration Anatomic Shell Recalled for Packaging Defect
FDA (Devices) · 2020-05-27
- ModerateStryker Restoration Anatomic Shell Recalled Due to Packaging Defect
FDA (Devices) · 2020-05-27