Zyoptix XP Microkeratome maxon motor, Ref #ZXP09183. The label shows the product is manufactured by Bausch & Lomb Incorporated, Rochester, NY.
This recall has been terminated (originally issued October 22, 2008).
- Company
- Bausch & Lomb Inc
- Recall Initiated
- April 23, 2008
- Posted
- October 22, 2008
- Terminated
- April 2, 2012
- Recall Number
- Z-0103-2009
- Quantity
- 69 motors
- Firm Location
- Rochester, NY
- Official Source
- View on FDA website ↗
Reason for Recall
The plastic tip on the drive shaft may come off the shaft and cause the blade to stop oscillating.
Distribution
Worldwide Distribution --- including USA and countries of Brazil, The Netherlands, Canada, India, Malaysia, Mexico, and Singapore.
Lot / Code Info
Serial numbers: 77318901, 77318902, 77318903, 77318904, 77318905, 77318907, 77318910, 77318911, 77318913, 77318914, 77318915, 77318917, 77318918, 77318919, 77318922, 77318923, 77318924, 77318929, 77318930, 77318931, 77318932, 77504010, 77504012, 77504017, 77732304, 77732306, 77732308, 77732309, 77732310, 77732311, 77732312, 77732313, 77732314, 77732315, 77898709, 77898711, 78080303, 78080307, 78080308, 78080309, 78080310, 78080312, 78080313, 78080314, 78080315, 78080320, 78080322, 78080331, 78080337, 78207103, 78207104, 78207106, 78207107, 78207108, 78207111, 78207113, 78207114, 78207115, 78207116, 78207117, 78207118, 78207119, 78207120, 78207121, 78207122, 78207123, 78207124, 78207125, 78207129.
Root Cause
Device Design
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.