Z-2504-2019Class II

XP-CR Tibial Tray - Interlok 63mm Item # 195269

Name: Z-2504-2019 XP-CR Tibial Tray - Interlok 63mm Item # 195269
Creator: Zimmer Biomet, Inc.
Published: 2019-08-15
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2019-08-15 / Terminated / root cause: manufacturing process

FDA source

Zimmer Biomet, Inc. began a recall of XP-CR Tibial Tray - Interlok 63mm Item # 195269 on 2019-08-15. FDA classified it as Class II and gives the reason as "The locking bar not fully engaging". 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-2504-2019
Classification: Class II
Status: Terminated
Initiated: 2019-08-15
Posted: 2019-09-12
Terminated: 2021-04-16
Recalling firm: Zimmer GmbH
Product: XP-CR Tibial Tray - Interlok 63mm Item # 195269
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: The locking bar not fully engaging
Root cause tag: manufacturing process
FDA root cause: Manufacturing material removal
Action: 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.Complete Attachment 1 Certificate of Acknowledgement and send to [email protected]. This form will be returned even if you do not have affected products at your facility. 4.Retain a copy of the acknowledgement form with your recall records in the event of a compliance audit of your facilitys documentation. 5.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.There are no specific patient monitoring instructions related to this recall that are recommended beyond your existing follow-up schedule. 3.A visual and audible confirmation should be made to ensure complete locking bar insertion. 4.Complete Attachment 1 Certificate of Acknowledgement and send to [email protected]. 5.Retain a copy of the acknowledgement form with your recall records in the event of a compliance audit of your facilitys 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-
Quantity in commerce: 322 unit
Distribution: State NY IN OH MI GA SC FL MO WI MN ND SD NE NJ PA MD IL IA CA VA NC DC WV AR AL MS AL MI WA OR ID LA FL KS TN MA KY OK TX TX CT AZ NV NM MT WY CO UT DC WY Country: KOREA CHINA CANADA AUSTRALIA JAPAN EMEA SWEDEN ITALY
Product codes and lots: Lot Number 663420 993820 660430 660430R 262380 395340 445350 584240 562230 578990 579070 043840 159200 917670 996050 043840R 917670R 206800 090150 159210 352790 995940 352780 469480 321920 663450 258040 352770 966700 434250 434260 456730 274630 374760 672430 899750 041270 899710 041200 666860 278990 600750 712530 600750R 821250 821250R 450310 599050 599050R 199780 717140 943340 017920 076390 220020 220020R 175270 228580 175270R 199790 199790R 395350

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2504-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2503-2019	Class II	Terminated	Voluntary: Firm initiated	2019-09-18	2019-09-12
Z-2504-2019	Class II	Terminated	Voluntary: Firm initiated	2019-09-18	2019-09-12
Z-2505-2019	Class II	Terminated	Voluntary: Firm initiated	2019-09-18	2019-09-12
Z-2506-2019	Class II	Terminated	Voluntary: Firm initiated	2019-09-18	2019-09-12
Z-2507-2019	Class II	Terminated	Voluntary: Firm initiated	2019-09-18	2019-09-12
Z-2508-2019	Class II	Terminated	Voluntary: Firm initiated	2019-09-18	2019-09-12
Z-2509-2019	Class II	Terminated	Voluntary: Firm initiated	2019-09-18	2019-09-12
Z-2510-2019	Class II	Terminated	Voluntary: Firm initiated	2019-09-18	2019-09-12
Z-2511-2019	Class II	Terminated	Voluntary: Firm initiated	2019-09-18	2019-09-12
Z-2512-2019	Class II	Terminated	Voluntary: Firm initiated	2019-09-18	2019-09-12
Z-2513-2019	Class II	Terminated	Voluntary: Firm initiated	2019-09-18	2019-09-12
Z-2514-2019	Class II	Terminated	Voluntary: Firm initiated	2019-09-18	2019-09-12
Z-2515-2019	Class II	Terminated	Voluntary: Firm initiated	2019-09-18	2019-09-12
Z-2516-2019	Class II	Terminated	Voluntary: Firm initiated	2019-09-18	2019-09-12
Z-2517-2019	Class II	Terminated	Voluntary: Firm initiated	2019-09-18	2019-09-12
Z-2518-2019	Class II	Terminated	Voluntary: Firm initiated	2019-09-18	2019-09-12
Z-2519-2019	Class II	Terminated	Voluntary: Firm initiated	2019-09-18	2019-09-12
Z-2520-2019	Class II	Terminated	Voluntary: Firm initiated	2019-09-18	2019-09-12
Z-2521-2019	Class II	Terminated	Voluntary: Firm initiated	2019-09-18	2019-09-12
Z-2522-2019	Class II	Terminated	Voluntary: Firm initiated	2019-09-18	2019-09-12
Z-2523-2019	Class II	Terminated	Voluntary: Firm initiated	2019-09-18	2019-09-12
Z-2524-2019	Class II	Terminated	Voluntary: Firm initiated	2019-09-18	2019-09-12
Z-2525-2019	Class II	Terminated	Voluntary: Firm initiated	2019-09-18	2019-09-12
Z-2526-2019	Class II	Terminated	Voluntary: Firm initiated	2019-09-18	2019-09-12
Z-2527-2019	Class II	Terminated	Voluntary: Firm initiated	2019-09-18	2019-09-12
Z-2528-2019	Class II	Terminated	Voluntary: Firm initiated	2019-09-18	2019-09-12
Z-2529-2019	Class II	Terminated	Voluntary: Firm initiated	2019-09-18	2019-09-12
Z-2530-2019	Class II	Terminated	Voluntary: Firm initiated	2019-09-18	2019-09-12
Z-2531-2019	Class II	Terminated	Voluntary: Firm initiated	2019-09-18	2019-09-12
Z-2532-2019	Class II	Terminated	Voluntary: Firm initiated	2019-09-18	2019-09-12
Z-2533-2019	Class II	Terminated	Voluntary: Firm initiated	2019-09-18	2019-09-12
Z-2534-2019	Class II	Terminated	Voluntary: Firm initiated	2019-09-18	2019-09-12
Z-2535-2019	Class II	Terminated	Voluntary: Firm initiated	2019-09-18	2019-09-12
Z-2536-2019	Class II	Terminated	Voluntary: Firm initiated	2019-09-18	2019-09-12
Z-2537-2019	Class II	Terminated	Voluntary: Firm initiated	2019-09-18	2019-09-12

Product code JWH

K132873Class IIVanguard Xp Knee SystemBiomet, Inc. / cleared 2013-12-11

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)