Z-1159-2016Class II

Product 61 consists of all product under

Name: Z-1159-2016 Product 61 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 61 consists of all product under product code: JWH and same usage: Item no: 598003712 STD PRECOAT TIBIA PLATE S for use in total knee arthroplasty 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-1159-2016
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 61 consists of all product under product code: JWH and same usage: Item no: 598003712 STD PRECOAT TIBIA PLATE S 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: 39
Distribution: US Nationwide Distribution
Product codes and lots: lot no.: 61678240 61838251 61838252 61838253 61838254 61901158 61901159 61925016 61926797 61958844 61958845 61999206 61999207 62037903 62037904 62037905 62070148 62070149 62141260 62170961 62191179 62220224 62232384 62245104 62284609 62298550 62298551 62313021 62319305 62326309 62359946

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1159-2016
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

K933785Class IINext Generation Knee SystemZimmer, Inc. / cleared 1995-01-30

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)