Z-1117-2016Class II

Product 19 consists of all

Name: Z-1117-2016 Product 19 consists of all
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 19 consists of all product code: JDI and same usage: Item no: 765301101 CEM FEM ST 11X120 NOCOAT 765301201 CEM FEM ST 12X125 NOCOAT 765301301 CEM FEM... 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-1117-2016
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 19 consists of all product code: JDI and same usage: Item no: 765301101 CEM FEM ST 11X120 NOCOAT 765301201 CEM FEM ST 12X125 NOCOAT 765301301 CEM FEM ST 13X130 NOCOAT 765301401 CEM FEM ST 14X135 NOCOAT 765301501 CEM FEM ST 15X140 NOCOAT 765301601 CEM FEM ST 16X145 NOCOAT 763301300 CEM FEM ST FX 13 X 130 763301600 CEM FEM ST FX 16 X 145 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: 0
Distribution: US Nationwide Distribution
Product codes and lots: lot no.: 62222763 62240266 62268561 62284487 62294353 62310467 62320160 62346566 61846909 61859930 62028715 62069012 62114832 62237560 62278694 62284486 62298294 62305946 62310463 62330767 62340043 61864095 62028713 62038326 62086042 62100678 62114831 62215704 62284488 62291943 62305945 62311644 62317919 62320157 62320158 62340044 62363364 61866237 62105184 62215705 62268566 62284489 62294354 62303512 62311645 62330768 62065287 62211913 62268563 62284490 62299091 62320161 62333990 62299091N 61885871 62100679 62278695 62303703 62333992 62069011 62280472

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1117-2016
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

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)