FDA Device recall Z-1133-2016
Product 35 consists of all product under product code: JWH and same usage: Item no: 522007300 I/B II KNEE FLUTED ROD, 1 for use in total kn…
- FDA Device
- Class II
- terminated
- Published 2016-03-23
On 2016-03-23 the FDA classified a Class II recall of Product 35 consists of all product under product code: JWH and same usage: Item no: 522007300 I/B II KNEE FLUTED ROD, 1 for use in total kn… by Zimmer Manufacturing B V, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1133-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-01-11 |
| Published | 2016-03-23 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Zimmer Manufacturing B V |
| Distribution | US |
Product
Product 35 consists of all product under product code: JWH and same usage: Item no: 522007300 I/B II KNEE FLUTED ROD, 1 for use in total knee arthroplasty
Reason
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.
Identifiers
| code_info | lot no.: 62207450 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1133-2016%22
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