FDA Device recall Z-1118-2016
Product 20 consists of all prod oct under poduct code: KTT and same usage: Item no: 47116201900 COMPRESSION SCREW 1/2IN 47116202300 COMPRES…
- FDA Device
- Class II
- terminated
- Published 2016-03-23
On 2016-03-23 the FDA classified a Class II recall of Product 20 consists of all prod oct under poduct code: KTT and same usage: Item no: 47116201900 COMPRESSION SCREW 1/2IN 47116202300 COMPRES… 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-1118-2016 |
| 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 20 consists of all prod oct under poduct code: KTT and same usage: Item no: 47116201900 COMPRESSION SCREW 1/2IN 47116202300 COMPRESSION SCREW 1-1/2IN 47116202200 COMPRESSION SCREW 1-1/4IN 47116202400 COMPRESSION SCREW 1-3/4IN 47116202100 COMPRESSION SCREW 1IN 47116202000 COMPRESSION SCREW 3/4IN 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.: 61678184 61839111 61852988 61862260 61875843 61882261 61898918 61974385 61988314 62002243 62002244…lot no.: 61678184 61839111 61852988 61862260 61875843 61882261 61898918 61974385 61988314 62002243 62002244 62024181 62031621 62090117 62109252 62263147 61875838 61895890 61895891 61912706 62037827 61649744 61660679 61764382 61882257 61887223 61988311 61988312 61988313 62009735 62037784 62090119 62109257 62153293 62160886 62263160 62109261 61396164 61634704 61664774 61777417 61777418 61782841 61782843 61782845 61782848 61810565 61810566 61810567 61810568 61810569 61810570 61810571 61839106 61839107 61839108 61839109 61852999 61853001 61853002 61853005 61875839 61875854 61882265 61887219 61887220 61893994 61894002 61915563 61915564 61915565 61938456 61938457 61938458 61938459 61980692 61980694 61980696 61980698 61985662 61985665 61985670 61985676 62009730 62009731 62009732 62009734 62017442 62017443 62017444 62024184 62024185 62024186 62031633 62038976 62038977 62038978 62090115 62097349 |
|---|
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-1118-2016%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.