Z-0630-2019Class II

NexGen Complete Knee Solution Femoral Augment Block Distal only, 15mm, Size E with Screw Item Number...

Name: Z-0630-2019 NexGen Complete Knee Solution Femoral Augment Block Distal only, 15mm, Size E with Screw Item Number...
Creator: Zimmer Biomet, Inc.
Published: 2018-10-31
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2018-10-31 / Terminated / root cause: manufacturing process

FDA source

Zimmer Biomet, Inc. began a recall of NexGen Complete Knee Solution Femoral Augment Block Distal only, 15mm, Size E with Screw Item Number: 00599003523 NexGen Distal Femoral Augment Block is used... on 2018-10-31. FDA classified it as Class II and gives the reason as "Screw is missing from the package". 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-0630-2019
Classification: Class II
Status: Terminated
Initiated: 2018-10-31
Posted: 2018-12-18
Terminated: 2019-04-08
Recalling firm: Zimmer GmbH
Product: NexGen Complete Knee Solution Femoral Augment Block Distal only, 15mm, Size E with Screw Item Number: 00599003523 NexGen Distal Femoral Augment Block is used when femoral components can neither be downsized nor can be distally augmented by increasing the thickness of the cement mantle.
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: Screw is missing from the package
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Zimmer Biomet issued "URGENT MEDICAL DEVICE RECALL" Letter on 10/31/18 via email and FedEx to the consumer/user level, including any intermediate wholesale or retail consignees, distributors and Risk managers. Distributors responsibilities include locating and removing the product in their territory, as well as identifying hospitals that have previously used the product. Hospital risk managers responsibilities include the following: 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 must 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].
Quantity in commerce: 19 units
Distribution: Worldwide Distribution: US (nationwide) to states of: OH, FL, NJ, NY, OH, PA, TX, WV and to countries of: CANADA, AUSTRALIA, JAPAN, GERMANY, and NETHERLANDS.
Product codes and lots: Lot Number: 62925336 UDI Number: (01)00889024224131(17)250228(10)62925336

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0630-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0630-2019	Class II	Terminated	Voluntary: Firm initiated	2018-12-26	2018-12-18

Product code JWH

K152494Class IIZimmer NexGen Complete Knee Solution Tibial and Femoral AugmentsZimmer, Inc. / cleared 2015-11-25

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)