Reported Mar 2, 2016 · Terminated
NexGen LPS Flex Option Femoral NexGen LPS Flex Precoat Femoral prosthesis, knee, patellofemorotibial, semi-constrained,…
Zimmer Biomet, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Zimmer Biomet, Inc. · 1800 W Center St · Warsaw, IN · 46580-2304
Is this the product you have?
- NexGen LPS Flex Option Femoral NexGen LPS Flex Precoat Femoral prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing various sizes "" This device is indicated for patients with
- severe knee pain and disability due toRheumatoid 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. " CR-Flex and LPS-Flex porous coated femoral and tibial baseplate components may be used cemented or uncemented (biological fixation). CR-Flex HA/TCP porous coated femoral and tibial baseplate components may only be used uncemented. All other femoral, tibial baseplate and all-polyethylene patella components are indicated for cemented use only. " Specific
- uses with CR-Flex or LPS-Flex femoralsProvides increased flexion capability for patients who have both the flexibility and desire to increase their flexion range. The CR-Flex 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, 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 femoral, when used with the 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. " Specific
- Uses with NexGen LPS or LCCK femoralsThe LPS femoral is designed for use with both cruciate ligaments excised and when load bearing ROM is expected to be less than or equal to 130 degrees. The usage of the LCCK femoral is the same as the LPS with the exception that femoral bone loss can be accommodated by femoral stem extensions and augmentation. No varus/valgus constraint or other stability other than that provided by the NexGen LPS is provided when the LCCK femoral component is used with the LPS-Flex articular surfaces."
- Lot codes and dates
- Item numbers
00-5960-011-5100-5960-011-5200-5960-012-5100-5960-012-5200-5960-013-5100-5960-013-5200-5960-014-5100-5960-014-5200-5960-015-5100-5960-015-5200-5960-016-5100-5960-016-5200-5960-017-5100-5960-017-5200-5960-018-5100-5960-018-5200-5964-011-5100-5964-011-5200-5964-012-5100-5964-012-5200-5964-013-5100-5964-013-5200-5964-014-5100-5964-014-5200-5964-015-5100-5964-015-5200-5964-016-5100-5964-016-5200-5964-017-5100-5964-017-52
- Lot numbers
3,209 of 3,209 codes
110038191100382211003824110039551100397311003997110040421100408611004103110041041100410511004160110041661100417311004174110041881100419011004223110042521100425511004271110042801100430011004336110043731100437711004469110045031100454611004552110045591100456511004598110046281100462911004630110046541100467511004680110046821100470611004716110047221100472311004755110047561100475911004767110047681100479311004795110048211100487111004899110049011100490211004947110049491100497311005026
- Item numbers
- Amount recalled
- 115796
This recall covers 21 products
The agency filed one notice per product. You are reading one of them; the other 20 are below.
8 more are in the archive.
Where it was sold
- Nationwide
- FL
Why it was recalled
LDPE bag containing the implant adheres to the highly polished implant surface.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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