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Terminated

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.

FDA Recall Z-1641-2010 · Posted 2010-05-21

Recalling FirmStryker Communications Corp
Recall StatusTerminated
Product CodeFSY
Date Initiated2010-04-15
Date Terminated2011-01-24
Product Quantity608 (booms and lights)

Reason for Recall

Installation records are incomplete.

Firm Action

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 [email protected].

Root Cause

Employee error

Distribution Pattern

Nationwide Distribution

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K033132STRYKER SWITCHPOINT INFINITYStryker Communications Corp. · 2004-09-02K031068STRYKER VISUM SURGICAL LIGHTING SYSTEMStryker Endoscopy · 2003-08-12

Official Source

View FDA Recall →

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

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