Device 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.
Z-1633-2015
Product summary
- Event
- Event 70994
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,147 in total
- Official record key
device-enforcement:Z-1633-2015
Official wording
Reason: 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.
Code information: 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
Distribution pattern: Worldwide Distribution: US (nationwide) including PR and countries of: Australia, Canada, China, Brazil, France, Hong Kong, India, Italy, Mexico, Netherlands, Singapore, South Africa, Sweden, and Spain.
Derived failure modes
-
Unknown
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.