Product 19 consists of all product code: JDI and same usage: Item no:… — Class II medical device recall Z-1117-2016
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 number | Z-1117-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zimmer Manufacturing B.V., Mercedita, PR, United States |
| Recall initiated | 2016-01-11 |
| Classified | 2016-03-12 |
| Reported by FDA | 2016-03-23 |
| Terminated | 2017-04-13 |
| Distributed | Nationwide (US) |
| Quantity | 0 |
| Reason classes | sterility |
| Lot numbers | 61846909, 61859930, 61864095, 61866237, 61885871, 62028713, 62028715, 62038326, 62065287, 62069011, 62069012, 62086042, 62100678, 62100679, 62105184, 62114831, 62114832, 62211913, 62215704, 62215705, 62222763, 62237560, 62240266, 62268561, 62268563, 62268566, 62278694, 62278695, 62280472, 62284486, 62284487, 62284488, 62284489, 62284490, 62291943, 62294353, 62294354, 62298294, 62299091, 62299091N and 21 more |
| Model numbers | 11X120, 765301101CEM |
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
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-1117-2016. 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.