FDA Device recall Z-1633-2015
Stryker Howmedica Osteonics RESTORATION Acetabular Augment System
- FDA Device
- Class II
- terminated
- Published 2015-05-27
On 2015-05-27 the FDA classified a Class II recall of Stryker Howmedica Osteonics RESTORATION Acetabular Augment System by Stryker Howmedica Osteonics, citing 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 bar….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1633-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-08-15 |
| Published | 2015-05-27 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Stryker Howmedica Osteonics |
| Distribution | US |
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.
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.
Identifiers
| code_info | Ref #:Lot Number - 5096-4615:MMR8M8; 5096-4615:MMRLYD; 5096-4615:MNAYT7; 5096-5015:MMPO6K; 5096-5015:MMRWOJ; 5096-5015:…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
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All Stryker Howmedica Osteonics recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1633-2015%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.