Z-2555-2017Class II

Fem IM Nail 15mmdx46cm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail...

Name: Z-2555-2017 Fem IM Nail 15mmdx46cm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail...
Creator: Zimmer Biomet, Inc.
Published: 2017-02-28
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2017-02-28 / Terminated / root cause: packaging

FDA source

Zimmer Biomet, Inc. began a recall of Fem IM Nail 15mmdx46cm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants on 2017-02-28. FDA classified it as Class II and gives the reason as "Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged in two different package configurations due to packaging design verification test failures". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2555-2017
Classification: Class II
Status: Terminated
Initiated: 2017-02-28
Posted: 2017-03-20
Terminated: 2018-02-27
Recalling firm: Zimmer GmbH
Product: Fem IM Nail 15mmdx46cm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants
Product code: HSB Rod, Fixation, Intramedullary And Accessories
Reason for recall: Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged in two different package configurations due to packaging design verification test failures.
Root cause tag: packaging
FDA root cause: Packaging
Action: Zimmer Biomet initiated a field action for sterile-packaged implants packaged in two different package configurations due to packaging design verification test failures. Zimmer Biomet sent letters via Fed-Ex and e-mail dated 02/28/2017 to customers informing them of the recall, and instructing them to do the following: 1. Review this notification and ensure affected team members are aware of the contents. 2. Complete the Certification of Acknowledgement portion of Attachment 1 a. Return a digital copy to [email protected] within three (3) days. 3. Assist the Zimmer Biomet sales representative quarantine all affected product. 4. If after reviewing this notice customers have further questions or concerns, please call 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday. Calls received outside of the call center operating hours will receive a prompt to record a voicemail or be transferred to an oncall representative in the case of an emergency. Alternatively, questions may be sent by email to [email protected]. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA: MedWatch Reporting: Adverse reactions or quality problems experienced with the use of this product may be reported to the FDAs MedWatch Adverse Event Reporting program either online, by mail, or by fax. Online: www.fda.gov/medwatch/report.htm Mail: Use postage paid, pre-addressed form FDA 3500, available at: www.fda.gov/MedWatch/getforms.htm Fax: 1-800-FDA-0178 Under 21 CFR 803, manufacturers are required to report any serious injuries where a product has contributed or may have contributed to the event. Please keep Zimmer Biomet informed of any adverse events associated with this product or any other Zimmer Biomet product by emailing [email protected]. For questions regarding this recall call 574-371-3071.
Distribution: Worldwide Distribution - US (nationwide) Foreign: Argentina, Australia, Belgium, Brazil, Bridgend Wales, Canada, Chile, Colombia, Dominican Republic, England, Eschbach, France, India, Italy, Japan, Jordan, Korea, Malaysia, Mexico, Netherlands, Nicaragua, Panama, Peru, Russia, Saudi Arabia, Singapore, Spain, Switzerland, Taiwan, Thailand
Product codes and lots: Item Number:00225246015, Lot Number Expiry Date Before: March 2027

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2555-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2549-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-21	2017-06-14
Z-2550-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-21	2017-06-14
Z-2551-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-21	2017-06-14
Z-2552-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-21	2017-06-14
Z-2553-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-21	2017-06-14
Z-2554-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-21	2017-06-14
Z-2555-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-21	2017-06-14
Z-2556-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-21	2017-06-14
Z-2557-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-21	2017-06-14
Z-2558-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-21	2017-06-14
Z-2559-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-21	2017-06-14
Z-2560-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-21	2017-06-14
Z-2561-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-21	2017-06-14
Z-2562-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-21	2017-06-14
Z-2563-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-21	2017-06-14
Z-2564-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-21	2017-06-14
Z-2565-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-21	2017-06-14
Z-2566-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-21	2017-06-14
Z-2567-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-21	2017-06-14
Z-2568-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-21	2017-06-14
Z-2569-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-21	2017-06-14
Z-2570-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-21	2017-06-14
Z-2571-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-21	2017-06-14
Z-2572-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-21	2017-06-14
Z-2573-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-21	2017-06-14
Z-2574-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-21	2017-06-14
Z-2575-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-21	2017-06-14
Z-2576-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-21	2017-06-14
Z-2577-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-21	2017-06-14
Z-2578-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-21	2017-06-14
Z-2579-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-21	2017-06-14
Z-2580-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-21	2017-06-14
Z-2581-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-21	2017-06-14
Z-2582-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-21	2017-06-14
Z-2583-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-21	2017-06-14

Product code HSB

K965098Class IIIntramedullary Nail SystemZimmer, Inc. / cleared 1997-02-28

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)