FDA Medical Device Recalls (openFDA)
Exactech, Inc.: Optetrak Logic Comprehensive Knee Prosthesis System, Proximal Tibial Spacer and screws, size 3.5, 8mm, Catalog # 02-012-42-3508.
- Recall number
- Z-0953-2013
- Recalling firm
- Exactech, Inc.
- Product
- Optetrak Logic Comprehensive Knee Prosthesis System, Proximal Tibial Spacer and screws, size 3.5, 8mm, Catalog # 02-012-42-3508.
- Status
- Terminated
- Initiated
- 2013-02-01
- Posted
- 2013-03-15
- Terminated
- 2014-09-22
- Reason
- A dimensional mismatch was identified which can potentially allow for interference between devices.
- Root cause
- Device Design
- Action
- 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.
- Quantity
- 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.
- Lot, serial or model codes
- Catalog # 02-012-42-3508 All lot numbers
- 510(k) numbers
- ["K071738"]
- PMA numbers
- not on file
- Product code
- JWH
- Firm FEI
- 1038671
- Firm city
- Gainesville
- Firm state
- FL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28