Zimmer NexGen Augment Recalled for Missing Locking Screw
Zimmer, Inc. is recalling 20 units of NexGen Augment knee implants because they were packaged without the required locking screw, which may delay surgery.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard is a packaging error (missing component) that may delay surgery but does not present an immediate risk of serious injury or death, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Zimmer, Inc. is recalling 20 units of the NexGen Augment 5mm Distal Femoral Augment (Part number 00-5990-036-10, lot 62815809). These medical devices are intended for use in total knee arthroplasty when there is insufficient bone in the distal femur.
The recall was initiated because the affected lot was packaged without the locking screw. This screw is necessary to fix the augment to the femoral component during the procedure. The absence of the screw has the potential to delay surgery.
The affected units were distributed in the states of Indiana, Minnesota, Florida, and Illinois, as well as in Argentina and Germany. Healthcare facilities and patients who have received or are scheduled to receive this specific lot should contact Zimmer, Inc. for further instructions.
The recalled product
- Product
- NexGen Augment; 5mm Distal Femoral Augment;Part number 00-5990-036-10. Intended to be used in total knee arthroplasty when there is insufficient bone in the distal femur.
- Manufacturer
- Zimmer, Inc.
- Affected units
- 20
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 #00-5990-036-10
- lot 62815809
Distribution
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