FDA Medical Device Recalls (openFDA)
Zimmer, Inc.: Zimmer Segmental System (ZSS) Cemented Stem / ZSS Cemented Stem, Smooth Stem Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented or Non-Porous, Uncemented.
- Recall number
- Z-1219-2015
- Recalling firm
- Zimmer, Inc.
- Product
- Zimmer Segmental System (ZSS) Cemented Stem / ZSS Cemented Stem, Smooth Stem Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented or Non-Porous, Uncemented.
- Status
- Terminated
- Initiated
- 2015-02-05
- Posted
- 2015-02-27
- Terminated
- 2015-09-23
- Reason
- PMMA coating does not meet specifications. Area of the stem may be missing PMMA coating.
- Root cause
- 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
- 1 unit
- Distribution
- US Distribution to the state of TX
- Lot, serial or model codes
- Item No. 00-5852-052-10; Lot 62866438
- 510(k) numbers
- ["K101296"]
- PMA numbers
- not on file
- Product code
- LZO
- Firm FEI
- 1000220733
- Firm city
- Warsaw
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28