CLASS II Device recall · Reported 19 Jul 2017 · FDA Enforcement Report
Optetrak Logic CC Tibial Augment Screws recalled by Exactech
Exactech is recalling Exactech Optetrak Logic CC Tibial Augment Screws, distributed in California, New York. The recall was initiated on 7 Apr 2017 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2704-2017
- FDA event ID
- 77514
- Recalling firm
- Exactech, Gainesville, FL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 7 Apr 2017
- FDA classified
- 8 Jul 2017
- Reported
- 19 Jul 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Packaging Defects
- Device type
- Hip & Knee Implants
Timeline
| 7 Apr 2017 | Recall initiated by company | |
| 8 Jul 2017 | Classified by FDA | +92 days |
| 19 Jul 2017 | Published in enforcement report | +11 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Missing Screw in carton. Nine (9) serial numbers were identified as being inadvertently packaged as one per carton when two per carton are required.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Exactech Optetrak Logic CC 15mm Tibial Augment Screws
Where it was distributed
CA and NY.
Questions about this recall
Is Optetrak Logic CC Tibial Augment Screws recalled?
Yes. Exactech recalled Optetrak Logic CC Tibial Augment Screws on 7 Apr 2017. The recall is Class II and its status is Terminated. Recall number Z-2704-2017.
Why was it recalled?
Missing Screw in carton. Nine (9) serial numbers were identified as being inadvertently packaged as one per carton when two per carton are required.
Which lots are affected?
Catalog No. 02-012-50-9015; Serial #'s 4739530, 4739531, 4739532, 4739533, 4739534, 4739535, 4739536, 4739537, and 4739538.
Where was it sold?
CA and NY.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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Other Hip & Knee Implants recalls
All 3,097| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline convenience kits labeled as: Femoral Pack, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Arvis Surgical Navigation System Gen recalled by Kico Knee Innovation | Kico Knee Innovation | Nitrosamine Impurity | 19 states |
| Device | CLASS II | Veritas Standard Reverse Total Shoulder Veritas Standard recalled | restor3d | Device Malfunction | Nationwide |
| Device | CLASS II | Endo-Model, Replacement Set, Tibial Plateau, right/left, L, Uhmwpe recalled | Waldemar Link GmbH & Co. KG (Mfg Site) | Lead & Heavy Metals | IN |
| Device | CLASS II | U2 Total Knee System Femoral offset bushing recalled | United Orthopedic | Device Malfunction | Nationwide |