Zimmer Segmental System (ZSS) Cemented Stem / ZSS Cemented… recallZ-1219-2015 · Zimmer, Inc. · initiated Feb 5, 2015
Class II Terminated All recalls posted in February 2015
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
PMMA coating does not meet specifications. Area of the stem may be missing PMMA coating.
FDA root cause category: Process control
What the company is doing
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.
Recall details
- Recall number
- Z-1219-2015
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Feb 5, 2015
- Posted by the FDA
- Feb 27, 2015
- Recalling firm
- Zimmer, Inc.
- Quantity
- 1 unit
- Product code
- LZO
- FDA submissions
- K101296
- Distribution
- US Distribution to the state of TX
Product description
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 (models, lots, serial numbers)
Item No. 00-5852-052-10; Lot 62866438
Other devices under the same FDA submission
2 devices cleared under K101296 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- NA 00-5852-050-09Zimmer, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented2 reports
- NA 00-5852-050-11Zimmer, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented2 reports
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.
How recalls are matched to devices · Editorial policy · Report an error on this page