FDA Device recall Z-1139-2016
Product 41 consists of all product under product code: KTT and same usage: Item no: 119301042 LAG SCR 12.7D X 100MM STA 119301045 LAG SCR 1…
- FDA Device
- Class II
- terminated
- Published 2016-03-23
On 2016-03-23 the FDA classified a Class II recall of Product 41 consists of all product under product code: KTT and same usage: Item no: 119301042 LAG SCR 12.7D X 100MM STA 119301045 LAG SCR 1… 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-1139-2016 |
| 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 41 consists of all product under product code: KTT and same usage: Item no: 119301042 LAG SCR 12.7D X 100MM STA 119301045 LAG SCR 12.7D X 105MM STA 119301047 LAG SCR 12.7D X 110MM STA 119301050 LAG SCR 12.7D X 115MM STA 119301052 LAG SCR 12.7D X 120MM STA 119301055 LAG SCR 12.7D X 125MM STA 119301057 LAG SCR 12.7D X 130MM STA 119301060 LAG SCR 12.7D X 135MM STA 119301062 LAG SCR 12.7D X 140MM STA 119301070 LAG SCR 12.7D X 155MM STA 119301020 LAG SCR 12.7D X 55MM STAN 119301022 LAG SCR 12.7D X 60MM STAN 119301025 LAG SCR 12.7D X 65MM STAN 119301027 LAG SCR 12.7D X 70MM STAN 119301030 LAG SCR 12.7D X 75MM STAN 119301032 LAG SCR 12.7D X 80MM STAN 119301035 LAG SCR 12.7D X 85MM STAN 119300537 LAG SCR 12.7D X 90MM SHOR 119301037 LAG SCR 12.7D X 90MM STAN 119301040 LAG SCR 12.7D X 95MM STAN 119301542 LAG SCR 15.8D X 100MM LAR 119301545 LAG SCR 15.8D X 105MM LAR 119301547 LAG SCR 15.8D X 110MM LAR 119301550 LAG SCR 15.8D X 115MM LAR 119301552 LAG SCR 15.8D X 120MM LAR 119301555 LAG SCR 15.8D X 125MM LAR 119301557 LAG SCR 15.8D X 130MM LAR 119301520 LAG SCR 15.8D X 55MM LARG 119301522 LAG SCR 15.8D X 60MM LARG 119301525 LAG SCR 15.8D X 65MM LARG 119301532 LAG SCR 15.8D X 80MM LARG 119301535 LAG SCR 15.8D X 85MM LARG 119301537 LAG SCR 15.8D X 90MM LARG 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.: 61644212 61792526 61815349 61828043 61850984 61890427 61921816 61934581 61969233 62017629 62093240…lot no.: 61644212 61792526 61815349 61828043 61850984 61890427 61921816 61934581 61969233 62017629 62093240 62093241 62093243 62171309 62197649 62197650 62299114 62318135 62318136 62318137 62318138 62318150 61644213 61815350 61828044 61873638 61934582 62002277 62067293 62075869 62160328 62213281 62263054 62263055 62267127 62267128 62267129 62267130 62267131 62267133 62267135 62267136 62267137 62267138 62267139 62267140 62294218 62294225 62294226 62294228 61803056 61873639 61895894 61912747 61912749 62227211 62299118 62299127 62299132 62299134 61764436 62213282 62322533 62322535 62322537 62322612 62322616 62322620 62322623 62322637 62227216 62322865 62322866 62322867 62322868 62322870 62322871 62322875 62322881 62322883 62322885 62322881N 62322881P 61982440 62054519 62075872 37107680 62338654 62338655 62058551 62075873 61897704 62054521 62124276 62218067 61786382 62002271 62067291 62075871 |
|---|
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-1139-2016%22
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