Product 51 consists of all product under product code: JWH and same… — Class II medical device recall Z-1149-2016
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-1149-2016 |
|---|---|
| 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 | 29,525 |
| Reason classes | sterility |
| Lot numbers | 370856, 61627858, 61662514, 61662516, 61662517, 61662518, 61662531, 61667594, 61667597, 61667598, 61667602, 61667616, 61667624, 61680137, 61687053, 61687057, 61687072, 61687076, 61687098, 61687109, 61687111, 61687112, 61687113, 61711627, 61711636, 61711638, 61711640, 61711642, 61711662, 61711664, 61711665, 61711666, 61711671, 61711675, 61711678, 61711679, 61711685, 61759320, 61764603, 61764604 and 460 more |
| Model numbers | 598603701 |
Product
Product 51 consists of all product under product code: JWH and same usage: Item no: 598603701 NEXGEN OPTION STEMMED TIB 598603702 NEXGEN OPTION STEMMED TIB 598604701 NEXGEN OPTION STEMMED TIB 598604702 NEXGEN OPTION STEMMED TIB 598605701 NEXGEN OPTION STEMMED TIB 598605702 NEXGEN OPTION STEMMED TIB for use in total knee 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-1149-2016. 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.