OPTETRAK LOGIC Proximal Tibial Spacer & Screws (2) 2.5 LT BLUE Size 2.5, 8mm***STERILE***Match insert/spacer/tray color.
FDA device recall Z-2234-2012 · posted 2012-08-21 · Terminated
Recall details
- Recalling firm
- Exactech, Inc.
- Reason for recall
- Exactech, Inc. of Gainesville, FL recalled their Optetrak Proximal Tibial Spacer after the devices were determined to be dimensionally incompatible to mate as intended with the Logic Tibial Tray.
- Action taken
- The firm, Exactech, Inc., sent a "IMPORTANT PRODUCT RECALL NOTICE" date October 17, 2011 to its customers. The notice described the product, problem and actions to be taken. The customers were instructed to immediately cease distribution or use of these products; extend this information to their accounts that may have possession of this product; verify if they have any of the subject Logic size 2.5 Proximal Tibial Spacer products, complete and return the attached PRODUCT RECALL FAX NOTICE form within five (5) working days via fax to: 352-337-3915, and to contact the firm inventory representative to confirm quantities at the location. For questions regarding inventory restocking, please call 1-800-392-2832.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- JWH
- Quantity affected
- 70
- Distribution
- Nationwide distribution: USA including states of: AL, AZ, CO, FL, GA, IL, LA, MD, MN, NC, NJ, NY, OH, OK, PA, PR, TN, VA, and WA.
- Date initiated
- 2011-10-17
- Date posted
- 2012-08-21
- Date terminated
- 2013-11-07
- 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 |