FDA Device recall Z-0830-2016
LPS-FLEX GSF OPT prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer Various sizes¿ Product Usage "" T…
- FDA Device
- Class II
- terminated
- Published 2016-03-02
On 2016-03-02 the FDA classified a Class II recall of LPS-FLEX GSF OPT prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer Various sizes¿ Product Usage "" T… by Zimmer Biomet, citing LDPE bag containing the implant adheres to the highly polished implant surface.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0830-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-01-11 |
| Published | 2016-03-02 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Zimmer Biomet |
| Distribution | US |
Product
LPS-FLEX GSF OPT prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer Various sizes¿ Product Usage "" This device is indicated for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. Collagen disorders, and/or avascular necrosis of the femoral condyle. Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. Moderate valgus, varus, or flexion deformities. The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery. " The CR-Flex GSF and LPS-Flex GSF uncoated (Option) and precoat styles are intended for cemented use only. " The CR-Flex GSF and LPS-Flex GSF porous coated femoral components may be used cemented or uncemented (biological fixation). " Specific uses with CR-Flex GSF or LPS-Flex GSF femorals: Provides increased flexion capability for patients who have both the flexibility and desire to increase their flexion range. The CR-Flex GSF femoral, when used with 90-prefix NexGen CR articular surfaces, 00-prefix 10, 12 or 14 mm or 90-prefix 17 or 20 mm Prolong¿ Highly Crosslinked Polyethylene CR articular surfaces, or with Gender Solutions Natural-Knee Flex Congruent articular surfaces, is designed for use with a functional posterior cruciate ligament and when load bearing range of motion (ROM) is expected to be less than or equal to 155 degrees. The LPS-Flex GSF femoral, when used with LPS-Flex articular surfaces, is designed for use with both cruciate ligaments excised and when load bearing ROM is expected to be less than or equal to 155 degrees."
Reason
LDPE bag containing the implant adheres to the highly polished implant surface.
Identifiers
| code_info | Item numbers: 00-5764-013-51 00-5764-013-52 00-5764-014-51 00-5764-014-52 00-5764-015-51 00-5764-015-52 00-5764-…Item numbers: 00-5764-013-51 00-5764-013-52 00-5764-014-51 00-5764-014-52 00-5764-015-51 00-5764-015-52 00-5764-016-51 00-5764-016-52 00-5764-017-51 00-5764-017-52 Lots: 11003937 11004287 11004298 11004337 11004544 11004612 11004769 11004797 11004818 11005062 11005066 11005155 11005276 11005598 11005680 11005705 11005748 11005900 11005931 11005959 11005980 11006190 11006737 11006764 11006827 11006840 11006882 11006922 11006986 11007165 11007217 11007272 11007323 11007651 11007849 11007988 11008186 11008197 11008221 11008231 11008311 11400099 11400104 11400119 11400120 11400122 11400125 11400126 11400134 11400152 11400165 11400170 11400187 11400203 11400215 11400218 11400244 11400247 11400270 11400271 11400274 11400284 11400339 11400359 11400360 11400364 11400381 11400417 11400418 11400427 11400428 11400448 11400449 11400451 11400452 11400455 11400456 11400457 11400464 11400482 11400488 114004 |
|---|
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-0830-2016%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.