Recall Z-2118-2012
Exactech, Inc. · initiated June 15, 2012
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Equinoxe Reverse Shoulder Fracture Adapter Tray Screw Intended for Primary and Reverse Total Shoulder Arthroplasty.
Codes / lots: Catalog Number 324-11-00 Serial Range 1653706-2381151
Reason for recall
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
FDA-determined cause: Labeling False and Misleading
Action taken
Exatech sent an Important Voluntary Recall Notice dated June 18, 2012, to all affected customers. The Notice identified the affected product, the problem, and the action to be taken by the customer. Customers were instructed to immeidately case distribution or use of the affected product. Verify that they have the affected product. Contact their Exatech Inventory Representative for further instruction on how to return their products. The firm sent out recall notification to consignees. Customers were asked to complete and return the Voluntary Recall Fax Notice to 1-352-378-2617. Customers with questions should call 1-800-392-2832. For questions regarding this recall call 352-377-1140.
Details
- Recall number
- Z-2118-2012
- Initiated
- June 15, 2012
- Posted by FDA
- July 31, 2012
- Terminated
- July 3, 2013
- Product code
- KWS – Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
- Quantity
- 54,877 units for all products in Recall Event
- Distribution
- Worldwide Distribution - USA including FL, MO, MA, AL, KY, IN, NC, LA,PA, VA, OH, NY, ME, MI, TX, KS, TN, OK, NJ, WA, CO, GA, CA, MN, IA, OR, and IL and Internationaly to Austria, Luxenbourg, Sweden, Germany, Spain, France, Greece, Italy, Nederland, United Kingdom, Canada, India, Australia, Switzerland, and Sao Palo.
- Recalling firm
- Exactech, Inc., Gainesville, FL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2115-2012 Class II | Equinoxe Anatomic Replicator Plate Intended for Primary and Reverse Total Shoulder…Exactech, Inc. initiated a recall of Equinoxe Replicator Plates, Equinoxe Locking Screws, Equinoxe… | 06/15/2012Terminated |
| Z-2116-2012 Class II | Equinoxe Fixed Angle Replicator Plate Intended for Primary and Reverse Total Shoulder…Exactech, Inc. initiated a recall of Equinoxe Replicator Plates, Equinoxe Locking Screws, Equinoxe… | 06/15/2012Terminated |
| Z-2117-2012 Class II | Equinoxe Reverse Compression Screw Intended for Primary and Reverse Total Shoulder…Exactech, Inc. initiated a recall of Equinoxe Replicator Plates, Equinoxe Locking Screws, Equinoxe… | 06/15/2012Terminated |
| Z-2119-2012 Class II | Equinoxe Reverse Glenosphere Locking Screw Intended for Primary and Reverse Total…Exactech, Inc. initiated a recall of Equinoxe Replicator Plates, Equinoxe Locking Screws, Equinoxe… | 06/15/2012Terminated |
| Z-2120-2012 Class II | Octane-C Cervical, 6 Lordotic Intended for anterior cervical spine intervertebral body…Exactech, Inc. initiated a recall of Equinoxe Replicator Plates, Equinoxe Locking Screws, Equinoxe… | 06/15/2012Terminated |