Recall Z-2341-2010
Stryker Medical Div. of Stryker Corporation · initiated February 26, 2010
Product
Eye surgery stretcher with crank fowler, model 1069 Stryker Medical 3800 E. Centre Ave Portage MI 49002. Intended use: A stretcher used for eye surgery.
Codes / lots: 405058504, 405058609, 405058610, 405058611, 405058736, 405058737, 405058835, 405058912, 406059340, 406065514, 406065515, 406065516, 406066560, 406066561, 406066562, 406066607, 406066638, 406066639, 406066640, 406066641, 406066642, 406066657, 406066658, 406066659, 406066660, 406066685, 406066686, 406066687, 406066688, 406066715, 406066716, 406066717, 406066718, 406066719, 406066720, 406066781, 406066799, 406066800, 406066801, 406066872, 406066873, 406066874, 406066875, 406066897, 406066932, 406066933, 407061553, 407061554, 407061555, 407061578, 407061613, 407061614, 407061615, 407061616, 407061617, 407061631, 407061632, 407061633, 407061634, 407061635, 407061661, 407061662, 407061685, 407061738, 407061781, 407061782, 407061783, 407061784, 407061861, 407061862, 407061867, 407061868, 407061997, 407062009, 408062048, 408062049, 408062051, 408062052, 408062053, 408062054, 408062055, 408062088, 408062098, 408062109, 408062110, 408062191, 408062192, 408062193, 408062336, 408062337, 409062130, 409062137, 409062138, 409062139, 409062186, 409062188, 409062204, 409062205, 409062206, 409062207, 409062299, 409062302, 409062303, 409062304, 409062305, 409062330, 409062374, 410058642, 410058643…
Reason for recall
The fowler of the bed is raised by a crank. The crank cosnsists of a steel screw that moves through a brass nut. Over time the screw can wear the threads on the brass nut. The screw and the nut can become misaligned, causing a loud squealing noise when the screw comes in contact with the drive tube. In addition the fowler can become inopperable over time with excessive wear of the brass nut.
FDA-determined cause: Device Design
Action taken
The firm, Stryker Medical, sent an "Urgent Medical Device Correction" letter dated February 26, 2010, to all customers. The letter describes the product, problem and action to be taken by customers. The letter states that Stryker field service tech will contact the firm and perform device corrections within four months. The customers were instructed to locate the recalled stretchers and verify that there is no grinding noise when activating the fowler. If the fowler exhibited a grinding noise, the customers were instructed to remove the stretcher from service and contact the recalling firm at 800-STRYKER, option 3. Note: Do not put the stretcher back into service until it is repaired by our field service representative. The customers were also instructed to return the enclosed post card to confirm receipt of this notice; inform any new users and advise the firm of new locations if any of the listed stretchers were on loan or sold, and advise the firm of the obsolescence by providing the serial numbers if any of the listed stretchers were disposed of. If you have any urgent questions or concerns, contact (269) 324-6884. Normal hours are Monday-Friday 8am-5pm(EST).
Details
- Recall number
- Z-2341-2010
- Initiated
- February 26, 2010
- Posted by FDA
- September 1, 2010
- Terminated
- April 21, 2011
- Product code
- FNJ – Bed, Manual
- Quantity
- 911
- Distribution
- Worldwide distribution: USA and countries including Australia, Canada, Chile, China, France, Germany, Greece, Spain, Italy, Japan, South Africa, Taiwan, Korea, Singapore, and UK.
- Recalling firm
- Stryker Medical Div. of Stryker Corporation, Portage, MI
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2342-2010 | Eye surgery stretcher with crank fowler, model 1079 Stryker Medical 3800 E. Centre Ave…The fowler of the bed is raised by a crank. The crank consists of a steel screw that moves through a brass… | 02/26/2010Terminated |
| Z-2343-2010 | Service parts for Crank Screw Assembly (PN1069-042-010S and 1069-042110S) Stryker…The fowler of the bed is raised by a crank. The crank consists of a steel screw that moves through a brass… | 02/26/2010Terminated |