Stableloc (TM) Wrist External Fixation System, Quantity 1. Packaged labeled, "Stableloc Wrist Fixator System... Desc:stabeloc (TM) External Fixator Kit... Ref FX-4001-S... Manufactured or Distributed by: Acumed (R) 5885 NW Cornelius Pass Road, Hillsboro, OR 97124...STERILE"
FDA Recall Z-1154-2010 · Posted 2010-03-16
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Recalling FirmAcumed LLC
Recall StatusTerminated
Product CodeJEC
Date Initiated2008-07-09
Date Terminated2010-05-21
Product Quantity80 kits
Reason for Recall
Parts are non-functional. The user is unable to fully pass the fixator pins through the body of the Stableloc assembly as required. The kit may also be missing the set screw.
Firm Action
The firm sent "Urgent Field Safety Notice: Medical Device Recall" letters to customers 7/9-11/08. In addition, the firm sent the letter via e-mail to some of the customers. The notification advised the customer of the recall, identified the product, explained the reason, and asked the customer to locate and segregate any affected product. The customer was asked to notify their customers who they had distributed the affected product to and asked them to complete and return an enclosed response form. The firm provided a model recall letter for its agents/distributors to issue to users. Upon receipt of the response form, the firm will contact customers to arrange for replacement of any affected product. Questions should be directed to the "Distributor phone number" or Richard Snyder, Quality Manager at 1-888-627-9957.
Root Cause
Process control
Distribution Pattern
Worldwide Distribution -- USA, including states of VA, NC, FL, ME, WA, GA, TX and PA and countries of Spain, Japan and Greece.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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