Biotrak PLLA Pin, Resorbable Fixation System, Biotrak 20 mm Pin; sterile pin packaged in sterile bag, enclosed within a
FDA device recall Z-0073-2010 · posted 2009-10-23 · Terminated
Recall details
- Recalling firm
- Acumed LLC
- Reason for recall
- 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).
- Action taken
- 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.
- Root cause
- Pending
- Status
- Terminated
- Product code
- HWC
- Quantity affected
- 125
- Distribution
- Worldwide Distribution -- USA and South Africa.
- Date initiated
- 2009-08-21
- Date posted
- 2009-10-23
- Date terminated
- 2010-11-06
- Location
- Hillsboro, OR
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ARC SURGICAL BIOTRAK SCREW (K061763) | Arc Surgical, LLC | 2006-09-19 |