FDA Device recall Z-0608-2014
CPT Hip System, Parts 00-8114-002-10 and 00-8011-004-00 Hip joint metal/polymer semi-constrained cemented prosthesis
- FDA Device
- Class II
- terminated
- Published 2014-01-08
On 2014-01-08 the FDA classified a Class II recall of CPT Hip System, Parts 00-8114-002-10 and 00-8011-004-00 Hip joint metal/polymer semi-constrained cemented prosthesis by Zimmer, citing 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 bein….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0608-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-12-10 |
| Published | 2014-01-08 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Zimmer |
| Distribution | AZ, CA, CO, FL, KS, KY, MI, NC, NJ, NV, OH, OK, OR, PA, SC, TN, TX, WA, WI |
Product
CPT Hip System, Parts 00-8114-002-10 and 00-8011-004-00 Hip joint metal/polymer semi-constrained cemented prosthesis. The CPT Hip System is indicated for cemented use in: Patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, and nonunion of previous fractures of the femur. Patients with congenital hip dysplasia, protrusio acetabuli, or slipped capital femoral epiphysis. Patients suffering from disability due to previous fusion. Patients with previously failed endoprostheses and/or total hip components in the affected extremity. Patients with acute femoral neck fractures. 510(k) K960658
Reason
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.
Identifiers
| code_info | Part 00-8114-002-10, Lot 62424414 Part 00-8011-004-00, Lot 62406423 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0608-2014%22
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