Z-1051-2018Class II

PRCT MIS CR MOB PLT SZ 4 L PRCT MIS CR MOB PLT SZ 5 L PRCT MIS CR MOB PLT SZ 6 L PRCT MIS CR MOB PLT SZ 7 L...

Name: Z-1051-2018 PRCT MIS CR MOB PLT SZ 4 L PRCT MIS CR MOB PLT SZ 5 L PRCT MIS CR MOB PLT SZ 6 L PRCT MIS CR MOB PLT SZ 7 L...
Creator: Zimmer Biomet, Inc.
Published: 2017-11-29
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2017-11-29 / Terminated / root cause: packaging

FDA source

Zimmer Biomet, Inc. began a recall of PRCT MIS CR MOB PLT SZ 4 L PRCT MIS CR MOB PLT SZ 5 L PRCT MIS CR MOB PLT SZ 6 L PRCT MIS CR MOB PLT SZ 7 L PRCT MIS CR MOB PLT SZ 7 R PRCT MIS CR MOB PLT SZ 8... on 2017-11-29. FDA classified it as Class II and gives the reason as "The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag". 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-1051-2018
Classification: Class II
Status: Terminated
Initiated: 2017-11-29
Posted: 2018-03-14
Terminated: 2020-04-02
Recalling firm: Zimmer GmbH
Product: PRCT MIS CR MOB PLT SZ 4 L PRCT MIS CR MOB PLT SZ 5 L PRCT MIS CR MOB PLT SZ 6 L PRCT MIS CR MOB PLT SZ 7 L PRCT MIS CR MOB PLT SZ 7 R PRCT MIS CR MOB PLT SZ 8 L PRCT MIS CR MOB PLT SZ 8 R This device is indicated for patients with severe knee pain and disability
Product code: NJL Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing
Reason for recall: The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag.
Root cause tag: packaging
FDA root cause: Packaging
Action: A similar recall was initiated in January 2016 to remove remaining inventory packaged in the old bag. Further evaluation identified additional lots packaged in the old bag that were not included in the January 2016 recall; therefore, resulting in this new recall for the additional lots packaged in the old bag. A firm, Zimmer Biomet, sent an "Urgent Medical Device Recall" notices dated November 29, 2017 and response forms to customers. The notice described the product, problem and actions to be taken. The Customers should take the following 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 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. 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. Immediately return all affected product from your distributorship and from affected hospitals within your territory. a. Complete Attachment 1 Inventory Return Certification Form and send to [email protected] within three (3) days. b. For each return, send a copy of Attachment 1 to [email protected]. c. Include a hardcopy of Attachment 1 in each carton of your return shipment for immediate processing. d. Mark RECALL on the outside of the returned cartons. 4. Return the Additi
Quantity in commerce: 13,227 in total
Distribution: Worldwide Distribution: US (nationwide) and countries of: Argentina, Australia, Brazil, Bolivia, Canada, Chile, China, Colombia, Ecuador, El Salvador, India, Japan, Malaysia, Mexico, Netherlands, New Zealand, Nicaragua, Panama, Seoul-Korea, Singapore, Taiwan, Thailand, and UAE.
Product codes and lots: 00-5930-040-01 61774223 00-5930-040-01 61780003 00-5930-040-01 61774226 00-5930-040-01 61774225 00-5930-040-01 11005139 00-5930-050-01 61774236 00-5930-050-01 11004031 00-5930-060-01 61774234 00-5930-070-02 61780002 00-5930-070-01 62139076 00-5930-080-02 61774216 00-5930-080-01 61774229 00-5930-080-01 61780004 00-5930-080-02 61785662 00-5930-080-02 61774215

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1051-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1014-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-21	2018-03-14
Z-1015-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-21	2018-03-14
Z-1016-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-21	2018-03-14
Z-1017-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-21	2018-03-14
Z-1018-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-21	2018-03-14
Z-1019-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-21	2018-03-14
Z-1020-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-21	2018-03-14
Z-1021-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-21	2018-03-14
Z-1022-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-21	2018-03-14
Z-1023-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-21	2018-03-14
Z-1024-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-21	2018-03-14
Z-1025-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-21	2018-03-14
Z-1026-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-21	2018-03-14
Z-1027-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-21	2018-03-14
Z-1028-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-21	2018-03-14
Z-1029-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-21	2018-03-14
Z-1030-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-21	2018-03-14
Z-1031-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-21	2018-03-14
Z-1032-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-21	2018-03-14
Z-1033-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-21	2018-03-14
Z-1034-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-21	2018-03-14
Z-1035-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-21	2018-03-14
Z-1036-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-21	2018-03-14
Z-1037-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-21	2018-03-14
Z-1038-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-21	2018-03-14
Z-1039-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-21	2018-03-14
Z-1040-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-21	2018-03-14
Z-1041-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-21	2018-03-14
Z-1042-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-21	2018-03-14
Z-1043-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-21	2018-03-14
Z-1044-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-21	2018-03-14
Z-1045-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-21	2018-03-14
Z-1046-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-21	2018-03-14
Z-1047-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-21	2018-03-14
Z-1048-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-21	2018-03-14
Z-1049-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-21	2018-03-14
Z-1050-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-21	2018-03-14
Z-1051-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-21	2018-03-14
Z-1052-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-21	2018-03-14
Z-1053-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-21	2018-03-14
Z-1054-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-21	2018-03-14
Z-1055-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-21	2018-03-14
Z-1056-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-21	2018-03-14
Z-1057-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-21	2018-03-14
Z-1058-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-21	2018-03-14
Z-1059-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-21	2018-03-14
Z-1060-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-21	2018-03-14
Z-1061-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-21	2018-03-14

Product code NJL

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)