Stryker Equipment Delivery System (EDS); Ceiling Mounted Equipment Booms; Catalog Number: 0682000383, 0682000384, 0682000385(A-D), 0682000386(A-D), 0682000426, 0682000429(A-D), 0682000326, 0682000311, 0682000361, 0682000362, 0682000230, 0682000337, 0682000338, 0682000232, 0682000233, 0682000339, 0682000234, 0682000235, 0682000236, 0682000340, 0682000341, 0682000238, 0682000239, 0682000342, 0682000240, 0682000241, 0682000931, 0682000343, 0682000344, 0682000328, 0682000933, 0682000345, 0682000329, 0682000330, 0682000934, 0682000346, 0682000347, 0682000331, 0682000936, 0682000348, 0682000332, 0682000333, 0682000401, 0682000302, & 0682000327. The booms are ceiling mounted devices. They are available in articulating and non-articulating configurations, in single or tandem (pair) configuration, with different shelves configuration to allow for various load capacities. Intended for use as ceiling-mounted devices for supporting or positioning equipment in the surgical suite and/or delivers gases or electricity to these devices.
This recall has been terminated (originally issued May 21, 2010).
- Company
- Stryker Communications Corp
- Recall Initiated
- April 15, 2010
- Posted
- May 21, 2010
- Terminated
- January 24, 2011
- Recall Number
- Z-1641-2010
- Quantity
- 608 (booms and lights)
- Firm Location
- Flower Mound, TX
- Official Source
- View on FDA website ↗
Reason for Recall
Installation records are incomplete.
Distribution
Nationwide Distribution
Lot / Code Info
Lot Code: Product Installed Between January 1, 2008 and August 31, 2009.
Root Cause
Employee error
Action Taken
An Urgent: Medical Device Product Correction customer notification letter, dated 4/15/2010, has been sent out to all affected accounts via regular mail in the form of a certified, return request receipt letter. Accounts will receive a follow-up phone call from a Stryker Representative to schedule a re-inspection of equipment to see if it mets established critical specifications or not. The firm recommends that customers continue using all Stryker Communications products listed in the notice. Questions can be directed to Katie Blackwell at 972-410-7660 or via email at StrykerCommunicationsRA@stryker.com.