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Terminated

Stryker Renaissance Series Emergency Care wheeled stretcher, Model 1231, Stryker Medical, Portage, MI 49002

FDA Recall Z-0234-2008 · Posted 2007-11-10

Recalling FirmStryker Medical Div. of Stryker Corporation
Recall StatusTerminated
Product CodeFPO
Date Initiated2004-11-15
Date Terminated2010-10-27
Product Quantity81,367 (61,708 U.S. and 19,569 ex-U.S.) for all models.

Reason for Recall

The brake cams may crack or develop excessive wear, resulting in the brakes not locking the wheels, or the stretcher not being locked firmly in position.

Firm Action

The firm issued an Urgent Medical Device Correction Letter dated 9/24/07, to each consignee informing them of the problems, that the brakes on each affected stretcher needed to be inspected/tested and removed from service if brake problems were discovered, and that a Stryker service representative would be in contact to replace the brakes.

Root Cause

Component change control

Distribution Pattern

Worldwide-USA, Argentina, Australia, Brazil, Canada, Chile, China, Dubai, France, India, Italy, Japan, Germany, Greece, Hong Kong, Korea, Latin America, Malaysia, Mexico, Netherlands, Poland, Portugal, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, and United Kingdom.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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