Z-1143-2016Class II

Product 45 consists of all product under

Name: Z-1143-2016 Product 45 consists of all product under
Creator: Zimmer Manufacturing B.V.
Published: 2016-01-11
License: https://open.fda.gov/license/

Zimmer Manufacturing B.V. / initiated 2016-01-11 / Terminated / root cause: packaging

FDA source

Zimmer Manufacturing B.V. began a recall of Product 45 consists of all product under product code: JWH and same usage: Item no: 511007020 MGII KNEE SLF-TAP BONE ST 511007025 MGII KNEE SLF-TAP BONE ST... on 2016-01-11. FDA classified it as Class II and gives the reason as "As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile". 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-1143-2016
Classification: Class II
Status: Terminated
Initiated: 2016-01-11
Posted: 2016-03-12
Terminated: 2017-04-13
Recalling firm: Zimmer Manufacturing B.V.
Product: Product 45 consists of all product under product code: JWH and same usage: Item no: 511007020 MGII KNEE SLF-TAP BONE ST 511007025 MGII KNEE SLF-TAP BONE ST 511007030 MGII KNEE SLF-TAP BONE ST 511007035 MGII KNEE SLF-TAP BONE ST 511007040 MGII KNEE SLF-TAP BONE ST 511007045 MGII KNEE SLF-TAP BONE ST for use in total knee arthroplasty
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.
Root cause tag: packaging
FDA root cause: Packaging
Action: Zimmer Biomet sent an Urgent Medical Device Recall Letter, dated January 11, 2016, to Distributors, Sales Representatives, Operation Managers, and Risk Managers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to 1.Review the notification and ensure that relevant personnel are aware of the contents. 2. Assist your Zimmer Biomet sales representative with the quarantine of any affected product. 3. Your Zimmer Biomet sales representative will remove the recalled product from your facility. 4. Complete and return the attached Certificate of Acknowledgment form to [email protected]. 5. If after reviewing this notification you have further questions or concerns please call Customer Service at 1-800-348-2759, or contact your Zimmer Biomet Sales Representative.
Quantity in commerce: 3696
Distribution: US Nationwide Distribution
Product codes and lots: lot no.: 61814292 61817008 61920896 61953528 62021071 62021071N 61810760 61814293 61817010 61830536 61868946 61895893 61920897 61953529 62021042 62079774 62326383 61810761 61810762 61817013 61817014 61830551 61895895 61895896 62079775 61810763 61810764 61817016 61830553 61850598 61917456 62173492 62173493 62286109 62318820 62326381 61814296 61920901 61830534 61830534N

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1143-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1099-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-23	2016-03-12
Z-1100-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-23	2016-03-12
Z-1101-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-23	2016-03-12
Z-1102-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-23	2016-03-12
Z-1103-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-23	2016-03-12
Z-1104-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-23	2016-03-12
Z-1105-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-23	2016-03-12
Z-1106-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-23	2016-03-12
Z-1107-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-23	2016-03-12
Z-1108-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-23	2016-03-12
Z-1109-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-23	2016-03-12
Z-1110-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-23	2016-03-12
Z-1111-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-23	2016-03-12
Z-1112-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-23	2016-03-12
Z-1113-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-23	2016-03-12
Z-1114-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-23	2016-03-12
Z-1115-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-23	2016-03-12
Z-1116-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-23	2016-03-12
Z-1117-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-23	2016-03-12
Z-1118-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-23	2016-03-12
Z-1119-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-23	2016-03-12
Z-1120-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-23	2016-03-12
Z-1121-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-23	2016-03-12
Z-1122-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-23	2016-03-12
Z-1123-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-23	2016-03-12
Z-1124-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-23	2016-03-12
Z-1125-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-23	2016-03-12
Z-1126-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-23	2016-03-12
Z-1127-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-23	2016-03-12
Z-1128-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-23	2016-03-12
Z-1129-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-23	2016-03-12
Z-1130-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-23	2016-03-12
Z-1131-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-23	2016-03-12
Z-1132-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-23	2016-03-12
Z-1133-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-23	2016-03-12
Z-1134-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-23	2016-03-12
Z-1135-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-23	2016-03-12
Z-1136-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-23	2016-03-12
Z-1137-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-23	2016-03-12
Z-1138-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-23	2016-03-12
Z-1139-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-23	2016-03-12
Z-1140-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-23	2016-03-12
Z-1141-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-23	2016-03-12
Z-1142-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-23	2016-03-12
Z-1143-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-23	2016-03-12
Z-1144-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-23	2016-03-12
Z-1145-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-23	2016-03-12
Z-1146-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-23	2016-03-12
Z-1147-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-23	2016-03-12
Z-1148-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-23	2016-03-12
Z-1149-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-23	2016-03-12
Z-1150-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-23	2016-03-12
Z-1151-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-23	2016-03-12
Z-1152-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-23	2016-03-12
Z-1153-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-23	2016-03-12
Z-1154-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-23	2016-03-12
Z-1155-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-23	2016-03-12
Z-1156-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-23	2016-03-12
Z-1157-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-23	2016-03-12
Z-1158-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-23	2016-03-12
Z-1159-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-23	2016-03-12
Z-1160-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-23	2016-03-12
Z-1161-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-23	2016-03-12
Z-1162-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-23	2016-03-12
Z-1163-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-23	2016-03-12
Z-1164-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-23	2016-03-12
Z-1165-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-23	2016-03-12
Z-1166-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-23	2016-03-12
Z-1167-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-23	2016-03-12
Z-1168-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-23	2016-03-12
Z-1169-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-23	2016-03-12
Z-1170-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-23	2016-03-12

Product code JWH

K892800Class IIMg II Porous Total Knee SystemZimmer, Inc. / cleared 1989-08-03

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)