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U.S. Department of Health and Human Services

Class 2 Device Recall Styker Impression Mattress

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 Class 2 Recall
Styker Impression Mattress
see related information
Date Posted May 23, 2011
Recall Status1 Terminated on October 07, 2011
Recall Number Z-2240-2011
Recall Event ID 58487
Product Classification Mattress, Flotation Therapy, Non-Powered - Product Code IKY
Product Stryker, Impression, Non-Powered Mattress, Model 2980, Stryker Medical, Portage, MI. The Impression non-powered mattress is recommended for use in the prevention of pressure ulcers. It is intended for use on Stryker frames and on other frames supporting a 84" x 35" x 6" mattress.
Code Information Model number 2980: 09AC000234, 09AC000235, 09AC000236, 09AC000237, 09AC000238, 09AC000239, 09AC000240, 09AC000241, 09AC000242, 09AC000243, 09AC000244, 09AC000245, 09AC000246, 09AC000247, 09AC000248, 09EA000807, 09EA000808, 09EA000809, 09EA000810, 09EA000811, 09EA000812, 09EA00081, 09EA000814, 09EA000815, 09EA000816, 09EA000817, 09EA000818, 09EA000819, 09EA000820, 09EA000821, 09EA000822, 09EA000823, 09EA000824, 09EA000825, 09EA000826, 09EA000827, 09EA000828, 09EA000829, 09EA000830, 09EA000831, 09FA000833, 09FA000834, 09FA000835, 09FA000836, 09FA000837, 09FA000838, 09FA000839, 09FA000840, 09FA000841, 09FA000842, 09FA000843, 09FA000844, 09FA000845, 09FA000846, 09FA000847, 09FA000848, 09FA000849, 09FA000850, 09FA000851, 09FA000852, 09FA000853, 09FA000854, 09FA000855, 09FA000856, 09FA000857, 09FA000858, 09FA000859, 09FA000860, 09FA000861, 09FA000862, 09FA000863, 09FA000864, 09FA000865, 09FA000866, 09FA000867, 09FA000868, 09FA000869, 09FA000870, 09FA000871, 09FA000872, 09FA000898, 09FA000899, 09FA000900, 09FA000901, 09FA000902, 09FA000903, 09GA000920, 09GA000921, 09GA000922, 09GA000923, 09GA000924, 09GA000925, 09GA000926, 09GA000927, 09GA000928, 09JA001517, 09JA001518, 09JA001519, 09JA001520, 09JA001521, 09JA001522, 09JA001523, 09JA001524, 09JA001561, 09JA001562, 09JA001563, 09JA001564, 09JA001565, 09JA001566, 09JA001567, 09JA001568, 09JA001569, 09JA001570, 09JA001571, 09JA001572, 09JA001573, 09JA001574, 09JA001575, 09JA001576, 09JA001577, 09JA001578, 09JA001579, 09JA001580, 09JA001581, 09JA001582, 09JA001583, 09JA001584, 09JA001585, 09JA001586, 09JA001587, 09JA001588, 09JA001589, 09JA001590, 09JA001591, 09JA001592, 09JA001593, 09JA001594, 09JA001595, 09JA001596, 09JA001597, 09JA001699, 09JA001700, 09JA001701, 09JA001702, 09JA001703, 09JA001704, 09KA002025, 09KA002026, 09KA002064, 09KA002065, 09KA002066, 09KA002067, 09KA002068, 09KA002069, 09KA002070, 09KA002071, 09KA002072, 09KA002073, 09KA002074, 09KA002075, 09KA002076, 09FA000896, 09FA000897, 09AC000249, 09AC000250, 09AC000251, 09AC000252, 09AC000253, 09DA000598, 09DA000599, 09EA000832, 09HA0001046, 09HA0001047, 09HA0001048, 09HA0001049, 09HA0001050, 09HA0001051, 09HA0001052, 09HA0001053, 09HA0001054, 09HA0001055, 09HA0001056, 09HA0001057, 09HA0001058, 09HA0001059, 09HA0001060, 09HA0001061, 09HA0001062, 09HA0001063, 09HA0001064, 09HA0001065, 09HA0001066, 09HA0001067, 09HA0001068, 09HA0001069, 09HA0001070, 09HA0001071, 09HA0001072, 09HA0001073, 09HA0001074, 09HA0001075, 09HA0001076, 09HA0001077, 09HA0001078, 09HA0001079, 09HA0001080, 09JA001698, 09JA001705, 09JA001706, 09JA001707, 09JA001708, 09HA001292 and 09HA001305.
Recalling Firm/
Manufacturer
Stryker Medical Division of Stryker Corporation
3800 East Centre Ave.
Portage, Michigan 49002
For Additional Information Contact Renata Silas
269-324-6609
Manufacturer Reason
for Recall
Affected mattresses may not conform to federal flammability standards.
FDA Determined
Cause 2
OTHER/UNDETERMINED: Pending
Action Stryker Medical sent an URGENT MEDICAL DEVICE RECALL letter dated April 29, 2011. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to locate all affected mattresses , remove the existing mattress cover, and replace it with an enclosed mattress cover. Customers were then to notify Stryker to confirm repairs. If the mattresses were loaned or sold, Stryker requested customers to notify the new user of the recall. Customers with questions or concerns, were asked to call 269-389-6689.
Quantity in Commerce 213
Distribution Worldwide Distribution - USA including California and the country of Canada.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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