Zimmer Recalls Nextgen Knee Replacement Jaw Instruments Due to Fracture Risk
Zimmer Inc. is recalling Nextgen Complete Knee Solution replacement jaws because the spring clip may fracture or fall off during use, potentially leaving fragments in the surgical site.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk of device fragments being left in the surgical site, which aligns with the rubric criteria for significant injury or structural defects.
Plain-English summary
Zimmer Inc. is recalling 65 units of the Nextgen Complete Knee Solution Replacement Jaw for Use with Femoral and Provisional Impactor/Extractor (REF 00-5901-026-40). The recalled instruments are non-sterile and are used to aid in positioning and inserting knee implant components. The recall affects specific lots: 62011774, 61870067, and 61813699.
The recall was initiated because the design of the spring clip for the jaw assembly was updated in March 2011 due to previous fractures, but Zimmer has received complaints that the spring clip is fracturing on this updated design. The spring clip may fracture or fall off the instrument during use, which could result in a device fragment being left in the surgical site.
The affected products were distributed worldwide, including the United States (nationwide), Singapore, China, Hong Kong, Canada, Australia, Japan, Europe, Germany, India, and Finland. Zimmer states that the replacement jaws will remain available for order until alternative instruments are in place, but they are required to be returned. Final lot numbers and manufacture dates will be provided in a subsequent status update.
The recalled product
- Product
- Nextgen Complete Knee Solution Replacement Jaw for Use with Femoral and Provisional Impactor/Extractor, REF 00-5901-026-40, Non-Sterile Zimmer, Warsaw Indiana The instrument is attached to the femoral implant or provisional to aid in positioning and inserting the components.
- Manufacturer
- Zimmer Inc.
- Hazard
- Affected units
- 65
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Part 00-5901-026-40 Lot 62011774
- 61870067
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Zimmer Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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