Zimmer Segmental System (ZSS) Cemented Stem / ZSS Cemented Stem, Smooth Stem Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented or Non-Porous, Uncemented.
FDA Recall Z-1219-2015 · Posted 2015-02-27
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Recalling FirmZimmer, Inc.
Recall StatusTerminated
Product CodeLZO
Date Initiated2015-02-05
Date Terminated2015-09-23
Product Quantity1 unit
Reason for Recall
PMMA coating does not meet specifications. Area of the stem may be missing PMMA coating.
Firm 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 [email protected].
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
Distribution Pattern
US Distribution to the state of TX
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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