Accolade and Restoration hip product; Catalog Number: 6720-0837 and 6721-0737
Reported: March 21, 2018 Initiated: July 21, 2017 #Z-0940-2018
Product Description
Accolade and Restoration hip product; Catalog Number: 6720-0837 and 6721-0737
Reason for Recall
Inner and outer sterile barriers not fully sealed.
Details
- Recalling Firm
- Howmedica Osteonics Corp.
- Units Affected
- 255
- Distribution
- Distributed in ten (10) states: AR, DE, FL, IL, IN, MI, NJ, OH, TN, and TX; and Canada, Sweden, United Kingdom, France, Spain, Italy, Japan, Romania, Colombia, Netherlands, and Australia.
- Location
- Mahwah, NJ
Frequently Asked Questions
What product was recalled? ▼
Accolade and Restoration hip product; Catalog Number: 6720-0837 and 6721-0737. Recalled by Howmedica Osteonics Corp.. Units affected: 255.
Why was this product recalled? ▼
Inner and outer sterile barriers not fully sealed.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 21, 2018. Severity: Moderate. Recall number: Z-0940-2018.
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