Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1844-2016Class II

EZ Slide Battery/line powered hydraulic table with removable leg section and 21 top slide General Purpose...

Skytron, LLC / initiated 2016-04-06 / Terminated / root cause: manufacturing process

Skytron, Div. The KMW Group, Inc began a recall of EZ Slide Battery/line powered hydraulic table with removable leg section and 21 top slide General Purpose Surgical Table Skytron EZ Slide Operating Table... on . FDA classified it as Class II and gives the reason as "The potential exists within the identified tables that incorrectly manufactured parts have been used in assembly. If a table is found to have these incorrectly manufactured parts, it is possible for the tables elevation...". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number
Z-1844-2016
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Skytron, LLC
Product
EZ Slide Battery/line powered hydraulic table with removable leg section and 21 top slide General Purpose Surgical Table Skytron EZ Slide Operating Table General Purpose Surgical Table
Product code
GDC Table, Operating-Room, Electrical
Reason for recall
The potential exists within the identified tables that incorrectly manufactured parts have been used in assembly. If a table is found to have these incorrectly manufactured parts, it is possible for the tables elevation column slide cap to become detached from the elevation column and could result in the loss of control of the table top and injury to the patient or staff.
Root cause tag
manufacturing process
FDA root cause
Reprocessing Controls
Action
Skytron sent an Urgent Medical Device Recall letter dated A,pril 4, 2016, to all affected customers. On April 6, 2016, URGENT: Medical Device Recall notifications were sent to the affected hospitals and distributors via certified mail. The notification instructed the hospital to identify and remove the affected product from use. The notification instructs the distributor to contact the hospital to schedule replacement. The recall notification included a description of the reason for the recall, affected product, and consignee responsibilities. The notification did not include instructions for responding to the formal recall notification, however the company did request acknowledgement via follow-up email. Please call Technical Services, at 616-656-1187 or 616-656-6403 with any questions. For after-hours support, please call 1-800-SKYTRON.
Quantity in commerce
458
Distribution
Nationwide Distribution to AL, AZ, CO, IA, WI, PA, TN, MA, TX, MI, FL, MS, LA, and CA.
Product codes and lots
Model number 3502. All units. Units entered commercial distribution between April 30, 2014 and July 24, 2014

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-1844-2016
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-1844-2016Class IITerminatedVoluntary: Firm initiated