Data Foundry

Medical device recalls 2016

Product 57 consists of all product code: JDI and same usage: Item no:… — Class II medical device recall Z-1155-2016

Terminated recall by Zimmer Manufacturing B.V., reported 2016-03-23, distributed nationwide. As a result of the insufficient sealer calibration data for product packaged in firm's Building II between Aug

Recall numberZ-1155-2016
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmZimmer Manufacturing B.V., Mercedita, PR, United States
Recall initiated2016-01-11
Classified2016-03-12
Reported by FDA2016-03-23
Terminated2017-04-13
DistributedNationwide (US)
Quantity0
Reason classessterility
Lot numbers61886896, 62012579, 62043474, 62055993, 62086025, 62086025N, 62141793, 62151833, 62224932, 62240754, 62264285, 62264285N, 62284483, 62284483N, 62284484, 62284485, 62284485N, 62293494, 62340084, 62362921, 62362923, 62362930
Model numbers763401000

Product

Product 57 consists of all product code: JDI and same usage: Item no: 763401000 PRESSFIT FEM ST FX 10 X 115 763401100 PRESSFIT FEM ST FX 11 X 1 763401200 PRESSFIT FEM ST FX 12 X 1 763401300 PRESSFIT FEM ST FX 13 X 1 763401400 PRESSFIT FEM ST FX 14 X 1 763401500 PRESSFIT FEM ST FX 15 X 1 For use in total or hemi hip arthroplasty

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1155-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.