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Z1 Hip System recallZ-1329-2025 · Zimmer, Inc. · initiated Feb 12, 2025

Class II Open, Classified All recalls posted in March 2025

Is my device affected?

  1. 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.
  2. 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.
  3. 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

There is a potential design issue with the Z1 Offset Stem Inserter leading to fracturing of the distal tip.

FDA root cause category: Under Investigation by firm

What the company is doing

An URGENT MEDICAL DEVICE RECALL notification dated 2/12/25 was sent to customers. Our records indicate that you may have received one or more of the affected products. The affected units were distributed between September 2024 and January 2025. 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. Review this notification for awareness of the contents. 2. For cases where the Z1 Offset Stem Inserter was used, increased clinical or radiographic monitoring may be required if the device fractured during use. If the Z1 Offset Stem Inserter was not used or if there was no evidence of fracture during use, there are no additional specific patient monitoring instructions related to this recall that are recommended beyond your existing follow-up schedule. 3. Complete Attachment 1

Recall details

Recall number
Z-1329-2025
Recall class
Class II
Status
Open, Classified
Initiated by the company
Feb 12, 2025
Posted by the FDA
Mar 24, 2025
Recalling firm
Zimmer, Inc.
Quantity
35 units
Product code
LZO
FDA submissions
K233476
Distribution
US Nationwide distribution.

Product description

Z1 Femoral Hip System, Product Number 611777612

Code information (models, lots, serial numbers)

UDI-DI: 00887868577888; Lot Numbers: 102646 102777 102778 104095 104324 105277

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

15 devices cleared under K233476 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

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