CPT Femoral Stem 12/14 Neck Taper Extended Offset,(item… recallZ-0062-2013 · Zimmer, Inc. · initiated Sep 13, 2012
Class II Terminated All recalls posted in October 2012
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Zimmer, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Zimmer Inc. is initiating a removal of the CPT Modular Stem (item 00-8011-001-00), CPT Stem Petite (item 00-8011-000-05; ) and CPT Femoral Stem 12/14 Neck Taper Extended Offset,(item 00-8114-001-10 ) because devices were packaged in incorrect cartons and distributed internationally and domestically. Zimmer received five complaints of this packaging issue.
FDA root cause category: Packaging change control
What the company is doing
Zimmer Inc. sent an "URGENT MEDICAL DEVICE RECALL-LOT SPECIFIC" letter dated September 13, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Consignees were asked to return all recalled product with a completed Inventory Return Certification Form. Contact the firm at 1-800-348-2759 for questions regarding this notice.
Recall details
- Recall number
- Z-0062-2013
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Sep 13, 2012
- Posted by the FDA
- Oct 15, 2012
- Recalling firm
- Zimmer, Inc.
- Quantity
- 59 both lots
- Product code
- JDI
- FDA submissions
- K960658
- Distribution
- Worldwide Distribution-USA (nationwide) including the states of Indiana and Oklahoma and the countries of Australia, Thailand, Malaysia, Germany, India, Bulgaria, Egypt, UK, Russian FED, Slovak, and Brazil.
Product description
CPT Femoral Stem 12/14 Neck Taper Extended Offset,(item 00-8114-001-10. CPT stems are primary cemented femoral hip stems used by surgeons in total hip arthroplasty.
Code information (models, lots, serial numbers)
Item 00-8114-001-10, lots 61947699 and 61952551
Other devices under the same FDA submission
23 devices cleared under K960658 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- CPT® 8114-01-10Zimmer, Inc. · Prosthesis, hip, semi-constrained, metal/polymer, cemented1 recall24 reports
- CPT® 8114-01Zimmer, Inc. · Prosthesis, hip, semi-constrained, metal/polymer, cemented1 recall11 reports
- CPT® 8114-02-10Zimmer, Inc. · Prosthesis, hip, semi-constrained, metal/polymer, cemented1 recall11 reports
- CPT® 8114-03-10Zimmer, Inc. · Prosthesis, hip, semi-constrained, metal/polymer, cemented1 recall11 reports
- CPT® 8114-00-10Zimmer, Inc. · Prosthesis, hip, semi-constrained, metal/polymer, cemented1 recall10 reports
- CPT® 8114-02Zimmer, Inc. · Prosthesis, hip, semi-constrained, metal/polymer, cemented1 recall9 reports
- CPT® 8114-02-30Zimmer, Inc. · Prosthesis, hip, semi-constrained, metal/polymer, cemented1 recall6 reports
- CPT® 8114Zimmer, Inc. · Prosthesis, hip, semi-constrained, metal/polymer, cemented1 recall4 reports
- CPT® 8114-02-18Zimmer, Inc. · Prosthesis, hip, semi-constrained, metal/polymer, cemented1 recall3 reports
- CPT® 8114-03Zimmer, Inc. · Prosthesis, hip, semi-constrained, metal/polymer, cemented1 recall2 reports
- CPT® 8114-04-10Zimmer, Inc. · Prosthesis, hip, semi-constrained, metal/polymer, cemented1 recall2 reports
- CPT® 8114-03-18Zimmer, Inc. · Prosthesis, hip, semi-constrained, metal/polymer, cemented1 recall1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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