Arthrosurface 35mm 13.5x32mm Taper Post Fixation Component; Catalog Number: 8135-0032, Part Number: 3135-0032. HemiCAP C
FDA device recall Z-1112-2015 · posted 2015-02-12 · Terminated
Recall details
- Recalling firm
- Arthrosurface, Inc.
- Reason for recall
- Fully threaded Taper Post Fixation components not cleared for marketing in the US with current indications.
- Action taken
- Arthosurface sent an Urgent Medical Device Recall letter on November 24, 2014 via UPS, to all affected customers. The letter informed consignees of the recall and asked them to return two completed forms, 1. Acknowledgement & Receipt Form and 2. Inventory Record via fax, email, or mail. Customers with questions were instcted to contact their local sales representatiave or email RA@arthrosurface.com. For questions regarding this recall call 508-528-4604.
- Root cause
- No Marketing Application
- Status
- Terminated
- Product code
- HSD
- Quantity affected
- 138
- Distribution
- Worldwide Distribution - USA nationwide. Internationally distributed to Europe, Canada, and Australia. Only products in US affected by this recall.
- Date initiated
- 2014-11-24
- Date posted
- 2015-02-12
- Date terminated
- 2015-03-27
- Location
- Franklin, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CONTOURED ARTICULAR PROSTHESIS (CAP) HUMERAL HEAD RESURFACING SYSTEM (K023096) | Std Mfg., Inc. | 2003-04-10 |