Zimmer Segmental System (ZSS) Cemented Stem / ZSS Cemented Stem, Smooth Stem Prosthesis, Hip, Semi-Constrained, Metal/Ce
FDA device recall Z-1219-2015 · posted 2015-02-27 · Terminated
Recall details
- Recalling firm
- Zimmer, Inc.
- Reason for recall
- PMMA coating does not meet specifications. Area of the stem may be missing PMMA coating.
- Action taken
- Zimmer sent an URGENT MEDICAL DEVICE RECALL - Lot Specific letter dated February 5, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Your Responsibilities 1. Review the notification and ensure affected personnel are aware of the contents. 2. Locate and remove from inventory the affected products identified above. 3. Return any affected product with missing PMMA coating per the PER process 4. Return the Notification Acknowledgment Form (Attachment 1) to corporatequality.postmarket@zimmer.com. 5. Please notify Zimmer if the hospital that you have distributed the affected product to has implanted the product. In addition, identify the surgeons that have used this product. 6. If after reviewing this notification you have further questions or concerns please call the customer call center at 1-877-946-2761 between 8:00 am and 5:00pm EST.
- Root cause
- Process control
- Status
- Terminated
- Product code
- LZO
- Quantity affected
- 1 unit
- Distribution
- US Distribution to the state of TX
- Date initiated
- 2015-02-05
- Date posted
- 2015-02-27
- Date terminated
- 2015-09-23
- Location
- Warsaw, IN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ZIMMER SEGMENTAL SYSTEM PROXIMAL FEMORAL COMPONENT AND SMALL DIAMETER STEM EXTENSIONS (K101296) | Zimmer, Inc. | 2010-07-30 |