Recall Z-0073-2010 ยท HWC Screw, Fixation, Bone
Acumed LLC
Biotrak PLLA Pin, Resorbable Fixation System, Biotrak 20 mm Pin; sterile pin packaged in sterile bag, enclosed within a box labeled Biotrak Resorbable Fixation System Biotrak 20 mm Pin REF 30170320-S Manufactured or Distributed by: ACUMED LLC 5885 NW Cornelius Pass Rd Hillsboro, OR 97124. The Acumed resorbable fixation devices are designed to provide fixation of specific fractures, osteotomi
| Date | Oct 23, 2009 (initiated Aug 21, 2009) |
| Status | Terminated |
| Reason | Labeling may contain 2 lot numbers and 2 model numbers. It was observed that the box top label (30170060-S, W67391) does not match the two side labels (3010320-S, W67385). The part and patient labeling inside the box match the side labels (30170320-S, W67385). |
| Root cause | Pending |
| Action | Urgent Notice: Device Recall Letters dated August 21, 2009 were sent to all consignees advising of the issue and and required action. Customers are to identify and quarantine the product having the affected lot code(s). Customers are to also return all product from the specified lot(s) to Acumed immediately. If product was further distributed, then those consignees should be notified of the recall and return of the product(s) should be requested. Questions should be directed to Acumed Customer Service at 1-888-627-9957. |
| Quantity | 125 |
| Distribution | Worldwide Distribution -- USA and South Africa. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K061763 | ARC SURGICAL BIOTRAK SCREW Arc Surgical, LLC, Sep 19, 2006 |