Z-1219-2015Class II

Zimmer Segmental System (ZSS) Cemented Stem / ZSS Cemented Stem, Smooth Stem Prosthesis, Hip...

Name: Z-1219-2015 Zimmer Segmental System (ZSS) Cemented Stem / ZSS Cemented Stem, Smooth Stem Prosthesis, Hip...
Creator: Zimmer, Inc.
Published: 2015-02-05
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2015-02-05 / Terminated / root cause: manufacturing process

FDA source

Zimmer, Inc. began a recall of Zimmer Segmental System (ZSS) Cemented Stem / ZSS Cemented Stem, Smooth Stem Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented or Non-Porous... on 2015-02-05. FDA classified it as Class II and gives the reason as "PMMA coating does not meet specifications. Area of the stem may be missing PMMA coating". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1219-2015
Classification: Class II
Status: Terminated
Initiated: 2015-02-05
Posted: 2015-02-27
Terminated: 2015-09-23
Recalling firm: Zimmer GmbH
Product: Zimmer Segmental System (ZSS) Cemented Stem / ZSS Cemented Stem, Smooth Stem Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented or Non-Porous, Uncemented.
Product code: LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Reason for recall: PMMA coating does not meet specifications. Area of the stem may be missing PMMA coating.
Root cause tag: manufacturing process
FDA 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 [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.
Quantity in commerce: 1 unit
Distribution: US Distribution to the state of TX
Product codes and lots: Item No. 00-5852-052-10; Lot 62866438

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1219-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1219-2015	Class II	Terminated	Voluntary: Firm initiated	2015-03-11	2015-02-27

Product code LZO

K101296Class IIZimmer Segmental System Proximal Femoral Component and Small Diameter Stem ExtensionsZimmer, Inc. / cleared 2010-07-30

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)