Exactech, Inc.: 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

Agency Publication Date: July 31, 2012

Affected Products

Product: Equinoxe Anatomic Replicator Plate Intended for Primary and Reverse Total Shoulder Arthroplasty

Sizes: 1.5 mm: Catalog Number 300-10-15 Serial Range 1653131-2381151 4.5 mm: Catalog Number 300-10-45 Serial Range 1622046-2381151

Product: Equinoxe Fixed Angle Replicator Plate Intended for Primary and Reverse Total Shoulder Arthroplasty.

Size: 0mm Catalog Number: 300-25-00 Serial Range: 1999574-2381151

Product: Equinoxe Reverse Compression Screw Intended for Primary and Reverse Total Shoulder Arthroplasty.

Sizes: 4.5x18mm Catalog # 320-20-18 Serial Range 1610445-2381151 4.5x22mm Catalog # 320-20-22 Serial Range 1610391-2381151 4.5x26mm Catalog # 320-20-26 Serial Range 1611237-2381151 4.5x30mm Catalog # 320-20-30 Serial Range 1617556-2381151 4.5x34mm Catalog # 320-20-34 Serial Range 1611290-2381151 4.5x38mm Catalog # 320-20-38 Serial Range 1610260-2381151 4.5x42mm Catalog # 320-20-42 Serial Range 1630006-2381151 4.5x46mm Catalog # 320-20-46 Serial Range 1644317-2381151

Product: Equinoxe Reverse Shoulder Fracture Adapter Tray Screw Intended for Primary and Reverse Total Shoulder Arthroplasty.

Catalog Number 324-11-00 Serial Range 1653706-2381151

Product: Equinoxe Reverse Glenosphere Locking Screw Intended for Primary and Reverse Total Shoulder Arthroplasty.

Catalog Number 324-15-05 Serial Range 1620549-2381151

Product: Octane-C Cervical, 6¿ Lordotic Intended for anterior cervical spine intervertebral body fusion procedures at one level (C3-C7).

Sizes: 5 mm Catalog # 05-010-02-0605 All serial numbers 6 mm Catalog # 05-010-02-0606 All serial numbers 7 mm Catalog # 05-010-02-0607 All serial numbers 8 mm Catalog # 05-010-02-0608 All serial numbers 9 mm Catalog # 05-010-02-0609 All serial numbers 10mm Catalog # 05-010-02-0610 All serial numbers 11mm Catalog # 05-010-02-0611 All serial numbers 12mm Catalog # 05-010-02-0612 All serial numbers

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 62566

Status: Resolved

Manufacturer: Exactech, Inc.

Manufactured In: United States

Units Affected: 6 products (54,877 units for all products in Recall Event)

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.