Z-2183-2018Class II

Vanguard Knee System PS Tibial Bearing, Part Number 183621 Intended for use in knee joint replacement...

Name: Z-2183-2018 Vanguard Knee System PS Tibial Bearing, Part Number 183621 Intended for use in knee joint replacement...
Creator: Zimmer Biomet, Inc.
Published: 2018-05-11
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2018-05-11 / Terminated / root cause: labeling and UDI

FDA source

Zimmer Biomet, Inc. began a recall of Vanguard Knee System PS Tibial Bearing, Part Number 183621 Intended for use in knee joint replacement procedures on 2018-05-11. FDA classified it as Class II and gives the reason as "The label master file was errantly set up as a 63/37mm instead of a 63/67mm. There is no 63/37 size offered, and the product is laser marked with the correct size". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2183-2018
Classification: Class II
Status: Terminated
Initiated: 2018-05-11
Posted: 2018-06-01
Terminated: 2019-11-21
Recalling firm: Zimmer GmbH
Product: Vanguard Knee System PS Tibial Bearing, Part Number 183621 Intended for use in knee joint replacement procedures.
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: The label master file was errantly set up as a 63/37mm instead of a 63/67mm. There is no 63/37 size offered, and the product is laser marked with the correct size.
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: The firm, Zimmer Biomet, sent an "Urgent Medical Device Recall (Removal)" letters dated 5/11/2018 to customers on 5/11/18. The letters described the product, problem and actions to be taken. The letters instruct customers to perform the following actions: 1. Review this notification and ensure 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 Form to Zimmer Biomet. a. For each return, send a copy of Attachment 1 to [email protected]. b. Include a hardcopy of Attachment 1 with your shipment for immediate processing. c. Mark the outside of the returning product box(es) clearly with RECALL. 5. Distributors will notify their accounts to which the product was further distributed and to locate and return products from these accounts in accordance with local regulations. 6. Retain a copy of your field action acknowledgement and product return forms for your records in the event of a compliance audit of your facility. 7. If after reviewing this notice you have further questions or concerns please call the customer call center 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 voice mail prompt or be transferred to an on-call representative in the event of an emergency. Alternatively, your questions may be emailed to [email protected].
Quantity in commerce: 169
Distribution: Worldwide distribution: US (nationwide) to states of: AR, CA, FL, GA, IL, IN, KS, MI, MN, MS, NC, OH, PA, TN, TX, and WV and country of: Canada.
Product codes and lots: UDI: (01)00880304673885(17)230222(10)120150, Lot Number: 120150; UDI: (01)00880304673885(17)201203(10)140700, Lot Number: 140700; UDI: (01)00880304673885(17)211125(10)173480, Lot Number: 173480; UDI: (01)00880304673885(17)210520(10)205730, Lot Number: 205730; UDI: (01)00880304673885(17)210822(10)294370, Lot Number: 294370; UDI: (01)00880304673885(17)210310(10)338750, Lot Number: 338750; UDI: (01)00880304673885(17)210902(10)421970, Lot Number: 421970; UDI: (01)00880304673885(17)210916(10)516680, Lot Number: 516680; UDI: (01)00880304673885(17)210411(10)678370, Lot Number: 678370; UDI: (01)00880304673885(17)220603(10)700470, Lot Number: 700470; UDI: (01)00880304673885(17)201015(10)722060, Lot Number: 722060; UDI: (01)00880304673885(17)230130(10)775330, Lot Number: 775330; UDI: (01)00880304673885(17)220620(10)858220, Lot Number: 858220; UDI: (01)00880304673885(17)211101(10)888080, Lot Number: 888080; UDI: (01)00880304673885(17)220221(10)992290, Lot Number: 992290

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2183-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2183-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-20	2018-06-13

Product code JWH

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)