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U.S. Department of Health and Human Services

Class 2 Device Recall Stryker Medical StairPRO StairChair

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  Class 2 Device Recall Stryker Medical StairPRO StairChair see related information
Date Initiated by Firm November 18, 2008
Date Posted February 04, 2009
Recall Status1 Terminated 3 on October 27, 2010
Recall Number Z-0649-2009
Recall Event ID 50178
Product Classification patient transport device, - Product Code FPP
Product Stryker Medical Stair-PRO Stair-Chair with wheels and a track system, patient transport device, Model 6252.
Code Information Serial numbers 080940553, 080940768, 080940600, 080940601, 080940831, 080940592, 080940899, 080940821, 080940822, 080940766, 080940767, 080940597, 080940642, 080940643, 080940832, 080940833, 080940834, 080940835, 080940836, 080940580, 080940581, 080940825, 080940639, 080940595, 080940596, 080940589, 080940765, 080940838, 080940839, 080940840, 080940607, 080940608, 080940829, 080940594, 080940582, 080940583, 080940584, 080940611, 080940612, 080940613, 080940830, 080940763, 080940826, 080940827, 080940871, 080940644, 080940859, 080940860, 080940861, 080940862, 080940863, 080940864, 080940865, 080940866, 080940867, 080940868, 080940869, 080940828, 080940593, 080940760, 080940761, 080940898, 080940837, 080940551, 080940552, 080940752, 080940769, 080940873, 080940874, 080940875, 080940876, 080940877, 080940641, 080940770, 080940843, 080940247, 080940248, 080940762, 080940842, 080940753, 080940754, 080940755, 080940756, 080940757, 080940758, 080940759, 080940841, 080940587, 080940588, 080940585, 080940586, 080940771, 080940550, 080940645, 080940646, 080940647, 080940648, 080940649, 080940750, 080940751, 080940823, 080940824, 080940870, 080940764 and 080940872.
Recalling Firm/
Manufacturer		 Stryker Medical Div. of Stryker Corporation
3800 E. Centre Ave.
Portage MI 49002
For Additional Information Contact
800-869-0770 Ext. 6902
Manufacturer Reason
for Recall		 Handle could come off. The bolts may back out over time, resulting in a risk of dropping the patient and/or injury to transport personnel, a delay in medical treatment, or a delay in evacuation.
FDA Determined
Cause 2		 Process control
Action Consignees were notified by Urgent Medical Device Correction letter dated 11/18/08 and given the serial numbers of their units, an upgrade kit and instructions for performing replacement of the bolts. Consignees were informed Stryker will perform the upgrade if requested.
Quantity in Commerce 105
Distribution Worldwide Distribution: USA, India, Netherlands and United Kingdom.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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