Z-1120-2016Class II

Product 22 consists of all product under

Name: Z-1120-2016 Product 22 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 22 consists of all product under product code: JDI and same usage: Item no: 811400218 CPT 12/14 COCR REVISION S 811400318 CPT 12/14 COCR REVISION S... 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-1120-2016
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 22 consists of all product under product code: JDI and same usage: Item no: 811400218 CPT 12/14 COCR REVISION S 811400318 CPT 12/14 COCR REVISION S 811400420 CPT 12/14 COCR REVISION S 811400423 CPT 12/14 COCR REVISION S 811400426 CPT 12/14 COCR REVISION S 811400010 CPT 12/14 COCR SIZE 0 EXT 811400000 CPT 12/14 COCR SIZE 0 STD 811400110 CPT 12/14 COCR SIZE 1 EXT 811400100 CPT 12/14 COCR SIZE 1 STD 811400210 CPT 12/14 COCR SIZE 2 EXT 811400200 CPT 12/14 COCR SIZE 2 STD 811400230 CPT 12/14 COCR SIZE 2 XEX 811400310 CPT 12/14 COCR SIZE 3 EXT 811400300 CPT 12/14 COCR SIZE 3 STD 811400330 CPT 12/14 COCR SIZE 3 XEX 811400410 CPT 12/14 COCR SIZE 4 EXT 811400400 CPT 12/14 COCR SIZE 4 STD 811400430 CPT 12/14 COCR SIZE 4 XEX 811400510 CPT 12/14 COCR SIZE 5 EXT 811400500 CPT 12/14 COCR SIZE 5 STD 811400530 CPT 12/14 COCR SIZE 5 XEX For use in total or hemi hip arthroplasty
Product code: JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
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: 16
Distribution: US Nationwide Distribution
Product codes and lots: lot no.: 61907682 62038367 62106797 62161479 62240743 62268577 62344683 62030932 62106796 62148557 62206538 62240742 62303507 62352823

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1120-2016
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 JDI

K030265Class IICpt 12/14 Hip Prostheses, Model 00-8114-040/050-00Zimmer, Inc. / cleared 2003-03-04

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)