Optetrak Logic Comprehensive Knee Prosthesis System, Proximal Tibial Spacer and screws, size 3.5, 8mm, Catalog # 02-012-
FDA device recall Z-0953-2013 · posted 2013-03-15 · Terminated
Recall details
- Recalling firm
- Exactech, Inc.
- Reason for recall
- A dimensional mismatch was identified which can potentially allow for interference between devices.
- Action taken
- Exactech Inc. sent a *** Important *** Product Market Recall Notice dated January 30, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. 1. Customers were instructed to immediately cease distribution or use of these products. 2. Extend this information to your accounts that may have this product in their possession. 3. Verify if you have any of the subject Optetrak Logic Proxima Tibial Spacer (PTS) in the specified lots. Please complete the attached fax back form and return it to Exactech within the next 5 working days. Thank you for your prompt attention to this matter. For further questions please call (352) 377-1140.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- JWH
- Quantity affected
- 123 devices
- Distribution
- Nationwide Distribution including the states of FL, AL, LA, PA, VA, IL, OH, NY, NC, KS, TN, NJ, CO, GA, CA, MD, MN, IN, & Puerto Rico.
- Date initiated
- 2013-02-01
- Date posted
- 2013-03-15
- Date terminated
- 2014-09-22
- Location
- Gainesville, FL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| EXACTECH OPTETRAK PROXIMAL TIBIAL SPACER (K071738) | Exactech, Inc. | 2007-08-15 |