Reported Mar 2, 2016 · Terminated
PRCT MIS CR MOB PLT prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing various…
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?
- PRCT MIS CR MOB PLT 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 porous coated femoral components may be used cemented or uncemented (biological fixation). CR-Flex HA/TCP porous coated femoral components may only be used uncemented. All other femoral and tibial baseplate components are indicated for cemented use only. " CR-Flex Mobile articular surfaces are intended for use with a functional posterior cruciate ligament (PCL). UC-Flex Mobile articular surfaces are intended for use with an absent or deficient PCL. "
- Specific uses with CR-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 CR-Flex Mobile or UC-Flex Mobile articular surfaces, is intended for use when load bearing range of motion (ROM) is expected to be less than or equal to 155 degrees."
- Lot codes and dates
- Item numbers
00-5930-010-0100-5930-010-0200-5930-020-0100-5930-020-0200-5930-030-0100-5930-030-0200-5930-040-0100-5930-040-0200-5930-040-4100-5930-040-4200-5930-050-0100-5930-050-0200-5930-060-0100-5930-060-0200-5930-070-0100-5930-070-0200-5930-080-0100-5930-080-02
- Lot numbers
421 of 421 codes
110021651100217011002753110027551100400611004022110040391100408411004256110043471100455811004696110050201100521111005470110055091100557011005571110058111100624311006977110076246178566461785665617856666178566761790305617908576179538561800855618008726180328761806782618124546181245561812456618124636181246761812468618124716181823361818234618224416182244261822449618224516182245261827033618270406182704161827045618270856182709461827096618330796183308061833081618331026183310561833106
- Item numbers
- Amount recalled
- 4567
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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