Z-2519-2023Class II

M/L Taper Hip Prosthesis Extended Offset, Reduced Neck Length, Size 4 (Item Number 00771100640) and Size 6...

Name: Z-2519-2023 M/L Taper Hip Prosthesis Extended Offset, Reduced Neck Length, Size 4 (Item Number 00771100640) and Size 6...
Creator: Zimmer, Inc.
Published: 2023-07-26
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2023-07-26 / Open, Classified / root cause: labeling and UDI

FDA source

Zimmer, Inc. began a recall of M/L Taper Hip Prosthesis Extended Offset, Reduced Neck Length, Size 4 (Item Number 00771100640) and Size 6 (Item Number 00771100440) on 2023-07-26. FDA classified it as Class II and gives the reason as "The outer package labeling and product etch are for a Size 6, however, the implant is a Size 4, and vice versa". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2519-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-07-26
Posted: 2023-09-07
Recalling firm: Zimmer GmbH
Product: M/L Taper Hip Prosthesis Extended Offset, Reduced Neck Length, Size 4 (Item Number 00771100640) and Size 6 (Item Number 00771100440)
Product code: JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Reason for recall: The outer package labeling and product etch are for a Size 6, however, the implant is a Size 4, and vice versa.
Root cause tag: labeling and UDI
FDA root cause: Mixed-up of materials/components
Action: An URGENT MEDICAL DEVICE RECALL notification letter dated 7/26/23 was sent to customers. Risk Manager Responsibilities: 1. Review this notification and ensure that affected personnel are aware of the contents. 2. If you have affected product at your facility, assist your Zimmer Biomet sales representative and quarantine all affected product. Your Zimmer Biomet sales representative will remove the affected product from your facility. 3. If the product has been further distributed, provide your customers with the recall notice and ensure documentation. 4. Complete Attachment 1 Certificate of Acknowledgement and send to [email protected]. This form shall be returned even if you do not have affected products at your facility. 5. Retain a copy of the acknowledgement form with your recall records in the event of a compliance audit of your facility s documentation. 6. If you have further questions or concerns after reviewing this notice, please call customer service at 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday. Calls received outside of call center operating hours will receive a voicemail prompt or be transferred to an on-call representative in the event of an emergency. Alternatively, your questions may be emailed to [email protected]. Surgeon Responsibilities: 1. You are receiving this notice because you have implanted one of the impacted stems based on our records. Review this notification for awareness of the contents. 2. There are no specific patient monitoring instructions related to this recall that are recommended beyond your existing follow-up schedule. It is anticipated that the fit of the stem would have been highly detectable, for example a physical size 4 stem sitting lower than expected in a bone prepared for size 6, or vice versa and the stem sitting proud. During surgery, the available offsets in femoral head implants may have provided the necessary flexibility to appropriate
Quantity in commerce: 24 units
Distribution: Worldwide - US Nationwide distribution in the states of AL, CA, GA, MI, NJ, PA, TN, and WI. The countries of Brazil, Canada, Netherlands.
Product codes and lots: Item Number: 00771100640, UDI-DI: 00889024131699, Lot Number: 65236202; Item Number: 00771100440, UDI-DI: 00889024131613, Lot Number: 65249215

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2519-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2519-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-09-13	2023-09-07

Product code JDI

K200823Class IIZimmer, Inc. Hip Joint Prostheses MR Labeling IZimmer, Inc. / cleared 2020-07-09

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)