Extremity Medical, IO FiX System Accessory. Catalog Number 101-00010. This screw measuring device is an accessory to the
FDA device recall Z-0752-2013 · posted 2013-01-30 · Terminated
Recall details
- Recalling firm
- Extremity Medical LLC
- Reason for recall
- Lag screw measurement is short (approximately 5 mm) when using current screw measuring device (p/n 101-00010) per the IO FIX Surgical Technique Rev C. which can lead to possible inappropriate implant size selection (e.g. shorter screw size selected).
- Action taken
- Extremity Medical LLC sent e-mail notification dated March 22, 2012, to all affected customers. The email identified the product the problem and the action to be taken by the customers. The email includes a buleeting which informes the customer that an upgrade to the existing instrumentation is being released. The upgrade will replace the existing gauge. Updated pdf versions of the technique guide are also included. Customers are instructed to return the recalled device after swapping out the recalled device with the replacement unit. Customers will be contacted by Extremity and Sales Reps should contact their principal. For further questions please call (973) 588-8980.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- HWC
- Quantity affected
- 93 units
- Distribution
- Worldwide Distribution -- Nationwide Distribution including the states of AR, AZ, CA, FL, GA, IL, IN, MD, MT, NC, NE, NH, NJ, NY, OH, PA, TN, TX, WI and WA.
- Date initiated
- 2012-03-22
- Date posted
- 2013-01-30
- Date terminated
- 2013-06-13
- Location
- Parsippany, NJ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PRESSON ELECTRODE (K121347) | Rhythmlink International, LLC | 2012-07-12 |
| IO FIX HAND, IO FIX FOOT, EXTREMITY MEDICAL SCREW SYSTEM (K101700) | Extremity Medical, LLC | 2010-10-12 |