16cm Minimally Invasive Attachment. For use with Motor Systems for cutting and shaping bones, including the spine and cr
FDA device recall Z-1037-2015 · posted 2015-02-02 · Terminated
Recall details
- Recalling firm
- The Anspach Effort, Inc.
- Reason for recall
- Customer complaint indicating the color bands on the MIA16-G1 were not correct.
- Action taken
- Anspach sent an "URGENT MEDICAL DEVICE RECALL" (Removal) letter dated December 10, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The firm requested the customer to 1) Immediately identify and set aside all product listed below 2) Review, complete, sign and return the attached reply form 3) Share this letter with others in your facility that need to be made aware of this recall 4) If you distribute any of the affected products to other services or facilities, please forward this letter as appropriate 5) Maintain awareness of this notice 7) Keep a copy of this notice. If you have any questions regarding this removal, please contact the Complaint Handling Unit Manager at 561-494-3673 or contact your Anspach Sales Representative.
- Root cause
- Environmental control
- Status
- Terminated
- Product code
- HBC
- Quantity affected
- 8
- Distribution
- US Distribution to the states of: NC and CA., and Internationally to Switzerland.
- Date initiated
- 2014-12-10
- Date posted
- 2015-02-02
- Date terminated
- 2016-05-09
- Location
- Palm Beach Gardens, FL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ANSPACH EG1 HIGH SPEED SYSTEM, G1 ATTACHMENTS (K133604) | The Anspach Effort, Inc. | 2014-01-10 |