Zyoptix XP Microkeratome maxon motor, Ref #ZXP09183. The label shows the product is manufactured by Bausch & Lomb Incorp
FDA device recall Z-0103-2009 · posted 2008-10-22 · Terminated
Recall details
- Recalling firm
- Bausch & Lomb Inc
- Reason for recall
- The plastic tip on the drive shaft may come off the shaft and cause the blade to stop oscillating.
- Action taken
- Phone calls were initiated on 4/28/08 and an Urgent Recall letter dated 4/23/08 was issued 4/28/08 via overnight mail to U.S. customers explaining the reason for recall. The letter also requested that customers stop using the motors identified and return of the motors for evaluation. A return form was enclosed.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- HNO
- Quantity affected
- 69 motors
- Distribution
- Worldwide Distribution --- including USA and countries of Brazil, The Netherlands, Canada, India, Malaysia, Mexico, and Singapore.
- Date initiated
- 2008-04-23
- Date posted
- 2008-10-22
- Date terminated
- 2012-04-02
- Location
- Rochester, NY
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ZYOPTIX XP MICROKERATOME (K040204) | Bausch & Lomb, Inc. | 2004-03-22 |