Tapered HD Upgrade Set, REF TSKHDUS, Non-Sterile, Rx Only, Product Usage Usage: Surgical instruments used in preparation
FDA device recall Z-1605-2015 · posted 2015-05-12 · Terminated
Recall details
- Recalling firm
- BioHorizons Implant Systems Inc
- Reason for recall
- BioHorizons Tapered HD Upgrade set was packaged with an incorrect drill component manufactured of stainless steel in place of the correct component manufactured from titanium.
- Action taken
- BioHorizons sent an Urgent Medical Device Field Correction letter on 04/16/2015 to affected customers. Non-responding customers will be notified after 30 days. The letter identified the affected product, problem and actions to be taken. For questions contact Customer Care Department at 888-246-8338.
- Root cause
- Process control
- Status
- Terminated
- Product code
- DZE
- Quantity affected
- 48 units
- Distribution
- US Nationwide in the states of: AL, FL, MS, VA, LA, CA, NC, TX, TN, OH, OK, VT, WA, MD, NY, SD, and SC.
- Date initiated
- 2015-04-16
- Date posted
- 2015-05-12
- Date terminated
- 2015-08-07
- Location
- Hoover, 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 TAPERED INTERNAL IMPLANT SYSTEM (K071638) | BioHorizons Implant Systems, Inc. | 2007-10-10 |