Stryker Howmedica Osteonics RESTORATION Acetabular Augment System; Howmedica Osteonics Corp., A subsidiary of Stryker Co
FDA device recall Z-1633-2015 · posted 2015-05-19 · Terminated
Recall details
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- 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.
- Action taken
- The firm, Stryker Orthopaedics, notified their Branches/Agencies via email on 8/15/2014 and sent an "Urgent Product Recall" letter dated 8/15/2014 with a Product Recall Acknowledgement Forms to their Branches/Agencies and consignees. The letter describes the product, issue, potential hazards and actions to be taken. The consignees were instructed to complete and return the attached Product Recall Acknowledgment Form within 5 days via fax to 855-251-3635; and return the affected product to the attention of Regulatory Compliance, Stryker Orthopaedics, 325 Corporate Drive, Mahwah NJ 07430. If you have any questions, feel free to contact Sr. Regulatory Compliance Specialist to 201-831-5826.
- Root cause
- Under Investigation by firm
- Status
- Terminated
- Product code
- LPH
- Quantity affected
- 1,147 in total
- Distribution
- 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 Spai
- Date initiated
- 2014-08-15
- Date posted
- 2015-05-19
- Date terminated
- 2018-01-05
- Location
- Mahwah, NJ
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| RESTORATION ACETABULAR WEDGE AUGMENTS (K102019) | Howmedica Osteonics | 2011-03-03 |