Z-1025-2017Class II

Active Articulation ArComXL Polyethylene Bearings Active Articulation ArComXL Bearings item XL-200152

Name: Z-1025-2017 Active Articulation ArComXL Polyethylene Bearings Active Articulation ArComXL Bearings item XL-200152
Creator: Zimmer Biomet, Inc.
Published: 2016-12-19
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2016-12-19 / Terminated / root cause: packaging

FDA source

Zimmer Biomet, Inc. began a recall of Active Articulation ArComXL Polyethylene Bearings Active Articulation ArComXL Bearings item XL-200152 on 2016-12-19. FDA classified it as Class II and gives the reason as "Product complaints indicated that the part and lot numbers on the packaging differed from the physical product inside the packaging. Risk of delay in surgery". 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-1025-2017
Classification: Class II
Status: Terminated
Initiated: 2016-12-19
Posted: 2017-01-13
Terminated: 2017-09-19
Recalling firm: Zimmer GmbH
Product: Active Articulation ArComXL Polyethylene Bearings Active Articulation ArComXL Bearings item XL-200152
Product code: LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Reason for recall: Product complaints indicated that the part and lot numbers on the packaging differed from the physical product inside the packaging. Risk of delay in surgery.
Root cause tag: packaging
FDA root cause: Under Investigation by firm
Action: Zimmer Biomet sent an Urgent Medical Device Recall (REMOVAL) LOT SPECIFIC notifications dated December 19, 2016, to the affected distributors and Risk Managers and Distributors via courier. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Risk Manager Responsibilities: 1. Review this notification and ensure affected personnel are aware of the contents. 2. Assist your Zimmer Biomet sales representative quarantine all affected product. 3. Your Zimmer Biomet sales representative will remove the affected product from your facility. 4. Complete Attachment 1 Certificate of Acknowledgement. a. Return a digital copy to [email protected]. b. Retain a copy of the Acknowledgement Form with your recall records in the event of a compliance audit of your facilities documentation. 5. If after reviewing this notice you 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 on-call representative in the case of an emergency. Alternatively, your questions may be sent by email to [email protected]. Distributor Responsibilities 1. Review this notification and ensure that affected team members are aware of the contents. 2. Immediately locate and quarantine affected product in your inventory. 3. Complete the Certification of Acknowledgement portion of Attachment 1 Inventory Return Certification Form a. Return a digital copy to [email protected] within three (3) days. 4. Immediately return all affected product from your distributorship and affected hospitals within your territory along with a completed Attachment 1 Inventory Return Certification
Quantity in commerce: 19
Distribution: USA (nationwide) and Internationally to ARGENTINA
Product codes and lots: Item XL-200152 Lot 339260 UDI (01)00880304491366(17)210713(10)339260

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1025-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1024-2017	Class II	Terminated	Voluntary: Firm initiated	2017-01-25	2017-01-13
Z-1025-2017	Class II	Terminated	Voluntary: Firm initiated	2017-01-25	2017-01-13

Product code LPH

K110555Class IIArcomxl Active ArticulationBiomet Manufacturing Corp / cleared 2011-03-24

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)