FDA Device recall Z-1144-2016
Product 46 consists of all product under product code: HWC and same usage: Item no: 114204012 MINI MAGNA-FX CANN SCREW 114204016 MINI MAGNA…
- FDA Device
- Class II
- terminated
- Published 2016-03-23
On 2016-03-23 the FDA classified a Class II recall of Product 46 consists of all product under product code: HWC and same usage: Item no: 114204012 MINI MAGNA-FX CANN SCREW 114204016 MINI MAGNA… 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-1144-2016 |
| 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 46 consists of all product under product code: HWC and same usage: Item no: 114204012 MINI MAGNA-FX CANN SCREW 114204016 MINI MAGNA-FX CANN SCREW 114204020 MINI MAGNA-FX CANN SCREW 114204024 MINI MAGNA-FX CANN SCREW 114204028 MINI MAGNA-FX CANN SCREW 114204032 MINI MAGNA-FX CANN SCREW 114204036 MINI MAGNA-FX CANN SCREW 114204040 MINI MAGNA-FX CANN SCREW 114204044 MINI MAGNA-FX CANN SCREW 114204048 MINI MAGNA-FX CANN SCREW 114204055 MINI MAGNA-FX CANN SCREW 114204065 MINI MAGNA-FX CANN SCREW 114204124 MINI MAGNA-FX CANN SCREW 114204126 MINI MAGNA-FX CANN SCREW 114204128 MINI MAGNA-FX CANN SCREW 114204130 MINI MAGNA-FX CANN SCREW 114204132 MINI MAGNA-FX CANN SCREW 114204134 MINI MAGNA-FX CANN SCREW 114204136 MINI MAGNA-FX CANN SCREW 114204138 MINI MAGNA-FX CANN SCREW 114204140 MINI MAGNA-FX CANN SCREW 114204142 MINI MAGNA-FX CANN SCREW 114204144 MINI MAGNA-FX CANN SCREW 114204146 MINI MAGNA-FX CANN SCREW 114204148 MINI MAGNA-FX CANN SCREW 114204150 MINI MAGNA-FX CANN SCREW 114204155 MINI MAGNA-FX CANN SCREW 114204160 MINI MAGNA-FX CANN SCREW 114204165 MINI MAGNA-FX CANN SCREW 114204170 MINI MAGNA-FX CANN SCREW 114205012 MINI MAGNA-FX CANN SCREW 114205016 MINI MAGNA-FX CANN SCREW 114205020 MINI MAGNA-FX CANN SCREW 114205024 MINI MAGNA-FX CANN SCREW 114205028 MINI MAGNA-FX CANN SCREW 114205032 MINI MAGNA-FX CANN SCREW 114205036 MINI MAGNA-FX CANN SCREW 114205040 MINI MAGNA-FX CANN SCREW 114205044 MINI MAGNA-FX CANN SCREW 114205048 MINI MAGNA-FX CANN SCREW 114205055 MINI MAGNA-FX CANN SCREW 114205065 MINI MAGNA-FX CANN SCREW 114205124 MINI MAGNA-FX CANN SCREW 114205126 MINI MAGNA-FX CANN SCREW 114205128 MINI MAGNA-FX CANN SCREW 114205130 MINI MAGNA-FX CANN SCREW 114205132 MINI MAGNA-FX CANN SCREW 114205134 MINI MAGNA-FX CANN SCREW 114205136 MINI MAGNA-FX CANN SCREW 114205138 MINI MAGNA-FX CANN SCREW 114205140 MINI MAGNA-FX CANN SCREW 114205142 MINI MAGNA-FX CANN SCREW 114205144 MINI MAGNA-FX CANN SCREW 114205146 MINI MAGNA-FX CANN SCREW 114205148 MINI MAGNA-FX CANN SCREW 114205150 MINI MAGNA-FX CANN SCREW 114205155 MINI MAGNA-FX CANN SCREW 114205160 MINI MAGNA-FX CANN SCREW 114205165 MINI MAGNA-FX CANN SCREW 114205170 MINI MAGNA-FX CANN SCREW Product Usage: A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted 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.: 62083732 62278719 62278734 62346023 62351544 62346023N 62351544N 61885643 62239545 62239546 6223954…lot no.: 62083732 62278719 62278734 62346023 62351544 62346023N 62351544N 61885643 62239545 62239546 62239547 62239548 62290035 62290040 61890456 62005296 62223791 62299098 62346024 61910239 62178894 62346025 61930882 62157290 62248127 62326540 61759543 61892650 61958361 62178895 62346026 62346027 62346026N 62346027N 61627269 61740666 61870977 62079036 62110010 62178896 62234077 62234078 62234079 62234080 62234081 62234082 62234084 62340974 62340975 62340978 62340980 62340983 62344456 62344457 62344459 62344460 62340974N 62340975N 62340978N 62340980N 62340983N 62344456N 62344457N 62344459N 62344460N 61620146 61740667 61839169 61930883 62083735 62223795 62339582 62339585 62339586 62339588 62339589 62339590 62339585N 62339586N 62339588N 62339589N 62339590N 61664666 61759547 61885657 61930884 62083738 62248129 62334669 62334674 62334676 62334680 62337028 62337030 62346148 62351545 62334669N 6 |
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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-1144-2016%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.