FDA Device recall Z-1810-2015
Navigation System II-Cart, 7700-100-000 with Articulated Arm Camera, 7700-103-001 and Articulated Arm Camera, 7700-103-001U Product Usage:…
- FDA Device
- Class II
- terminated
- Published 2015-06-24
On 2015-06-24 the FDA classified a Class II recall of Navigation System II-Cart, 7700-100-000 with Articulated Arm Camera, 7700-103-001 and Articulated Arm Camera, 7700-103-001U Product Usage:… by Stryker Instruments Div, citing stryker initiated a device recall of the Navigation System II-Cart, Camera Articulated Arm because there is a potential that the weld seam between the main stud and the two flaps….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1810-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-05-04 |
| Published | 2015-06-24 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Stryker Instruments Div |
| Distribution | US |
Product
Navigation System II-Cart, 7700-100-000 with Articulated Arm Camera, 7700-103-001 and Articulated Arm Camera, 7700-103-001U Product Usage: The Navigation System II-Cart is intended to be used as a platform for computer assisted surgery as part of the Stryker Navigation System. The intended use of the complete Stryker Navigation System is defined by the Stryker application modules.
Reason
Stryker initiated a device recall of the Navigation System II-Cart, Camera Articulated Arm because there is a potential that the weld seam between the main stud and the two flaps on the Articulated Arm was not welded in the correct location, which may result in a potential failure of the arm joint.
Identifiers
| code_info | Serial numbers 100019, 100984, 100965, 100295, 100979, 100773, 100946, 100797, 100947, 100956, 100966, 100649, 100967,…Serial numbers 100019, 100984, 100965, 100295, 100979, 100773, 100946, 100797, 100947, 100956, 100966, 100649, 100967, 100944, 100941, 100945, 100970, 100950, 100976, 100951, 100728, 100952, 100248, 100953, 100641, 100954, 100463, 100955, 100981, 100957, 100978, 100958, 100106, 100959, 100939, 100960, 100973, 100961, 100236, 100962, 100237, 100963, 100417, 100964. 100940, 100968, 100975, 100969, 100977, 100972, 100105, 100974, 100214, 100980, 100492, 100982, 100493, 100983, 100948, 100986, 100704, 100987, 100949, 100988, 100227, 100989, 100971, 100133, 100134, 100942. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1810-2015%22
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