FDA Device recall Z-1119-2016
Product 21 consists of all product under product code: JDI and same usage: Item no: 811400218 CPT 12/14 COCR REVISION S 811400318 CPT 12/14…
- FDA Device
- Class II
- terminated
- Published 2016-03-23
On 2016-03-23 the FDA classified a Class II recall of Product 21 consists of all product under product code: JDI and same usage: Item no: 811400218 CPT 12/14 COCR REVISION S 811400318 CPT 12/14… 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-1119-2016 |
| 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 21 consists of all product under product code: JDI and same usage: Item no: 811400218 CPT 12/14 COCR REVISION S 811400318 CPT 12/14 COCR REVISION S 811400420 CPT 12/14 COCR REVISION S 811400423 CPT 12/14 COCR REVISION S 811400426 CPT 12/14 COCR REVISION S 811400010 CPT 12/14 COCR SIZE 0 EXT 811400000 CPT 12/14 COCR SIZE 0 STD 811400110 CPT 12/14 COCR SIZE 1 EXT 811400100 CPT 12/14 COCR SIZE 1 STD 811400210 CPT 12/14 COCR SIZE 2 EXT 811400200 CPT 12/14 COCR SIZE 2 STD 811400230 CPT 12/14 COCR SIZE 2 XEX 811400310 CPT 12/14 COCR SIZE 3 EXT 811400300 CPT 12/14 COCR SIZE 3 STD 811400330 CPT 12/14 COCR SIZE 3 XEX 811400410 CPT 12/14 COCR SIZE 4 EXT 811400400 CPT 12/14 COCR SIZE 4 STD 811400430 CPT 12/14 COCR SIZE 4 XEX 811400510 CPT 12/14 COCR SIZE 5 EXT 811400500 CPT 12/14 COCR SIZE 5 STD 811400530 CPT 12/14 COCR SIZE 5 XEX Product Usage: Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.
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.: 61955193 61955194 61964624 61982550 62046482 62065282 62261923 62262772 62295082 62249027 62330762…lot no.: 61955193 61955194 61964624 61982550 62046482 62065282 62261923 62262772 62295082 62249027 62330762 62036886 62176426 62262773 61907680 62030928 62240741 62298284 62030929 61907674 61964631 61969290 61969291 62018466 62018468 62055978 62055980 62076923 62076924 62082567 62082568 62106792 62128913 62131432 62143850 62159845 62159846 62167370 62178690 62178691 62190353 62203977 62204524 62227026 62227027 62227029 62238072 62240247 62240730 62257224 62261914 62262774 62276442 62284459 62288119 62291920 62296540 62307970 62312487 62324098 62333959 62338563 62340055 62360134 62360140 61668394 61679041 61955610 61957414 61964634 61969286 61978765 61986788 61986790 62022714 62036889 62038366 62046483 62065284 62069521 62069522 62069524 62097046 62097047 62106790 62106791 62114854 62122106 62122107 62127729 62127730 62134924 62137237 62143848 62161474 62161475 62161476 62166255 62172022 |
|---|
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-1119-2016%22
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