Recall record at a glance
| Official record | Z-0480-2014 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Zimmer, Inc. |
| Report date | Dec 18, 2013 |
| Recall initiation date | Oct 31, 2013 |
| Quantity | 128 units |
| Location | Warsaw, IN, United States |
Official product description
NexGen Complete Knee Solutions Stemmed Tibial Component Precoat NexGen Tibial Baseplates are part of the NexGen systems of semi-constrained, non-linked condylar knee prosthesis. The 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.
Why the product was recalled
Two complaints were received in which it was reported that the stem would not lock into the tibia. Evaluation of the returned device found that the stemmed portion of the tibial plate would not hold the stem as the connection was too loose. The taper diameter was found to be oversized by .010 .
Distribution information
Worldwide Distribution - USA (nationwide) including the states of CA, IN, OH, GA, WI, IA, NE, NJ, PA, NY, MD, NC, AZ, NM, TX, CO, IL, AL, MI, WA, FL and KS, and the countries of China, Japan and Taiwan.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
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