Exactech Optetrak Logic CC 15mm Tibial Augment Screws
FDA device recall Z-2704-2017 · posted 2017-06-19 · Terminated
Recall details
- Recalling firm
- Exactech, Inc.
- 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.
- Action taken
- Consignees were initially contacted by phone on 04/07/2017. Consignees were sent a recall notice by mail, dated 04/13/2017. The notice requested that consignees immediately cease distribution/use of product, that the recall Extend the information to accounts in possession of the product Identify/quarantine any subject devices in your inventory Complete & return the attached Recall Inventory Response Form to Exactech within 5 business days at 2411 NW 66th Ct, Gainesville, FL 32653 or faxed to 352-337-3915. Questions from customers are to be directed to Kaya Davis at kaya@exac.com or 800-392-2832.
- Root cause
- Process control
- Status
- Terminated
- Product code
- JWH
- Quantity affected
- 9 devices
- Distribution
- CA and NY.
- Date initiated
- 2017-04-07
- Date posted
- 2017-06-19
- Date terminated
- 2020-08-04
- Location
- Gainesville, FL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Exactech Optetrak Logic CC (K150890) | Exactech, Inc. | 2015-05-29 |