Stryker Howmedica Osteonics Corp. Stryker Howmedica Osteonics RESTORATION Acetabular Augment System; Howmedica Osteonics Corp., A subsidiary of Stryker Corporation Made in USA Sterile. Hip prosthesis component. The RESTORATION Acetabular Wedge Augments provide multiple options to address the wide range of bone deficiencies encountered in acetabular revision. The augments provide support for the shell in the acetabulum with superior and/or posterior defects. Recall
Class II: 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
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Stryker Howmedica Osteonics RESTORATION Acetabular Augment System; Howmedica Osteonics Corp., A subsidiary of Stryker Corporation Made in USA Sterile. Hip prosthesis component. The RESTORATION Acetabular Wedge Augments provide multiple options to address the wide range of bone deficiencies encountered in acetabular revision. The augments provide support for the shell in the acetabulum with superior and/or posterior defects.
Brand
Stryker Howmedica Osteonics Corp.
Lot Codes / Batch Numbers
Ref #:Lot Number - 5096-4615:MMR8M8, 5096-4615:MMRLYD, 5096-4615:MNAYT7, 5096-5015:MMPO6K, 5096-5015:MMRWOJ, 5096-5015:MNADVA, 5096-5815:MNA40L, 5096-5820:MMR6HX, 5096-5825:MMRLD7, 5096-6225:MMPWO5, 5096-6225:MMRM2Y, 5096-6625:MMNM07
Products Sold
Ref #:Lot Number - 5096-4615:MMR8M8; 5096-4615:MMRLYD; 5096-4615:MNAYT7; 5096-5015:MMPO6K; 5096-5015:MMRWOJ; 5096-5015:MNADVA; 5096-5815:MNA40L; 5096-5820:MMR6HX; 5096-5825:MMRLD7; 5096-6225:MMPWO5; 5096-6225:MMRM2Y; 5096-6625:MMNM07
Stryker Howmedica Osteonics Corp. is recalling Stryker Howmedica Osteonics RESTORATION Acetabular Augment System; Howmedica Osteonics Corp., A sub due to The peel strength of the inner blister may have been below internal validated requirements. The strength of the seal is directly related to long term. This is a Class I recall, indicating a high risk of serious health consequences or death. Based on FDA medical device enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The peel strength of the inner blister may have been below internal validated requirements. The strength of the seal is directly related to long term shelf life of the sterile barrier.
Recommended Action
Per FDA guidance
Healthcare providers and patients should stop using the device and contact the manufacturer for further instructions. Report problems to FDA MedWatch.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026