Date Initiated by Firm | February 05, 2015 |
Date Posted | February 27, 2015 |
Recall Status1 |
Terminated 3 on September 23, 2015 |
Recall Number | Z-1219-2015 |
Recall Event ID |
70500 |
510(K)Number | K101296 |
Product Classification |
Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented - Product Code LZO
|
Product | Zimmer Segmental System (ZSS) Cemented Stem / ZSS Cemented Stem, Smooth Stem
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented or Non-Porous, Uncemented. |
Code Information |
Item No. 00-5852-052-10; Lot 62866438 |
Recalling Firm/ Manufacturer |
Zimmer, Inc. 1800 W Center St Warsaw IN 46580-2304
|
For Additional Information Contact | Consumer Relations Call Center 800-447-5633 |
Manufacturer Reason for Recall | PMMA coating does not meet specifications. Area of the stem may be missing PMMA coating. |
FDA Determined Cause 2 | Process control |
Action | 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. |
Quantity in Commerce | 1 unit |
Distribution | US Distribution to the state of TX |
Total Product Life Cycle | TPLC Device Report |
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database | 510(K)s with Product Code = LZO
|