Stableloc (TM) Wrist External Fixation System, Quantity 1. Packaged labeled, "Stableloc Wrist Fixator System... Desc:sta
FDA device recall Z-1154-2010 · posted 2010-03-16 · Terminated
Recall details
- Recalling firm
- Acumed LLC
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- JEC
- Quantity affected
- 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.
- Date initiated
- 2008-07-09
- Date posted
- 2010-03-16
- Date terminated
- 2010-05-21
- 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 |
|---|---|---|
| STABLELOC II EXTERNAL FIXATOR (K965029) | Acu Med, Inc. | 1997-02-19 |