Versys Build-Up Block The VerSys CRC Hip System is recall
Versys Build-Up Block The VerSys CRC Hip System is indicated for total hip arthroplasty in patients whose bone stock is of poor quality or inadequate…
Why was Versys Build-Up Block The VerSys CRC Hip System is recalled?
Zimmer is initiating a lot specific recall of the CPT Hip Stem, Versys Build-Up Block, and Trabecular Metal Reverse Glenosphere medical devices due to reports of the products being packaged in the incorrect outer carton. Product labels and patient labels are correct.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Part 00-7871-001-10 Lot 62359872
- Product
- Versys Build-Up Block The VerSys CRC Hip System is indicated for total hip arthroplasty in patients whose bone stock is of poor quality or inadequate…
- Recalling firm
- Zimmer, Inc.
- Quantity
- 3
- Distribution
- Worldwide Distribution -USA including OH, FL, WI, MI NJ, SC, CA, NC, PA, OR, WA, TN, KY, OK, KS, AZ, TX, CO, NV and Internationally to Germany. There have been 71 distribution events. Note that this product is lot controlled and may be distributed multiple times if it was returned and returned to the shelf. 7 units have been returned, including three through the complaint process, which leaves 64 affected units in the field subject to removal.
- Recall date
- January 8, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)