Single-stage 3.5mm Healing Abutment, 4 mm, REF SYHA40, Rx Only, STERILE R, gamma irradiated, expires 2014-44, CE 0473, B
FDA device recall Z-0321-2011 · posted 2010-11-04 · Terminated
Recall details
- Recalling firm
- BioHorizons Implant Systems Inc
- Reason for recall
- Healing abutment may not fully seat on the implant.
- Action taken
- Consignees were notified by an Urgent: Medical Device Recall letter on 09/07/2010. The letter identified the affected product and gave some background regarding the issue. It also stated the possible impact and the cases that were not affected. Consignees were instructed to contact BioHorizons Returns & Complaints Manager Rick Self at 205-986-1250, if they have unused product from the affected lot, for a Return Authorization Number and to receive replacements. The attached Notification Certification form is to be completed and returned via fax.
- Root cause
- Other
- Status
- Terminated
- Product code
- DZE
- Quantity affected
- 396
- Distribution
- Worldwide Distribution -- USA, including PA, MI, NY, AL, WA, and WV, and countries of Canada and Chile.
- Date initiated
- 2010-09-07
- Date posted
- 2010-11-04
- Date terminated
- 2010-12-13
- Location
- Birmingham, AL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BIOHORIZONS SINGLE-STAGE IMPLANT (K053152) | BioHorizons Implant Systems, Inc. | 2005-12-02 |