Stryker Howmedica Osteonics RESTORATION Acetabular Augment System — Class II medical device recall Z-1633-2015
Terminated recall by Stryker Howmedica Osteonics Corp., reported 2015-05-27, distributed nationwide. The peel strength of the inner blister may have been below internal validated requirements. The strength of th
| Recall number | Z-1633-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stryker Howmedica Osteonics Corp., Mahwah, NJ, United States |
| Recall initiated | 2014-08-15 |
| Classified | 2015-05-19 |
| Reported by FDA | 2015-05-27 |
| Terminated | 2018-01-05 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BR, CA, CN, ES, FR, HK, IN, IT, MX, NL, SE, SG, ZA |
| Quantity | 1,147 in |
| Reason classes | potency, sterility, packaging |
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 for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1633-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.