FDA (Devices) recall action 62566
The FDA (Devices) publishes a recall like this one as 6 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 6 pages.
Exactech, Inc. initiated a recall of Equinoxe Replicator Plates, Equinoxe Locking Screws, Equinoxe Compression Screw Kits, Equinoxe Fracture Adapter Tray Screws, and Octane-C Intervertebral fusion devices due to the firm determining that the device labeling identifies the affected parts as having a ten year shelf life; however, the packaging configuration that was used it qualified to a five year
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Exactech is recalling Equinoxe shoulder arthroplasty devices because the labeling incorrectly states a ten-year shelf life instead of the qualified five-year shelf life.
Exactech is recalling specific orthopedic implants because the labeling incorrectly states a ten-year shelf life, while the packaging is only qualified for five years.
Exactech is recalling Equinoxe and Octane-C devices because labeling incorrectly states a ten-year shelf life for parts qualified for five years.
Exactech is recalling Equinoxe shoulder arthroplasty devices because the labeling incorrectly states a ten-year shelf life, while the packaging is only qualified for five years.
Exactech is recalling Equinoxe shoulder arthroplasty devices because labeling incorrectly states a ten-year shelf life instead of the qualified five-year limit.
Exactech is recalling Equinoxe shoulder arthroplasty devices and related components because the labeling incorrectly states a ten-year shelf life instead of the qualified five-year shelf life.