Recall Z-1154-2010 ยท JEC Component, Traction, Invasive
Acumed LLC
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"
| Date | Mar 16, 2010 (initiated Jul 9, 2008) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Process control |
| 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 |
| Quantity | 80 kits |
| Distribution | Worldwide Distribution -- USA, including states of VA, NC, FL, ME, WA, GA, TX and PA and countries of Spain, Japan and Greece. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K965029 | STABLELOC II EXTERNAL FIXATOR Acu Med, Inc., Feb 19, 1997 |