Zimmer Biomet Recalls Segmental System Distal Femur Components
Zimmer Biomet is recalling 3,350 units of the Segmental System, ZSS Distal Femur, because the products exceeded tested weights, potentially compromising the sterile barrier.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk of a compromised sterile barrier, which poses a risk of harm (infection) even though no specific injuries or illnesses are reported in the source text.
Plain-English summary
Zimmer Biomet, Inc. is recalling 3,350 units of the Zimmer Segmental System, ZSS Distal Femur. The affected components are intended to replace the proximal femur, mid-shaft femur, distal femur, proximal tibia, and/or total knee in cases requiring extensive resection and restoration. The specific sizes involved are B-LT, B-RT, C-LT, and C-RT, with item numbers 00585001201, 00585001202, 00585001301, and 00585001302.
The recall was initiated because the products exceeded the weight previously tested. This condition creates a possibility of damage to the package and/or a compromised sterile barrier. The agency has classified this recall as Class II.
The affected units were distributed worldwide, including nationwide in the United States and in numerous international countries such as Canada, Germany, Japan, and Australia. Healthcare providers and facilities that have received these specific items should contact Zimmer Biomet for instructions on how to return or replace the devices.
The recalled product
- Product
- Zimmer Segmental System, ZSS Distal Femur. Sizes as follows: a. Size B-LT (Item No. 00585001201); b. Size B-RT (Item No. 00585001202); c. Size C-LT (Item No. 00585001301); d. Size C-RT (Item No. 00585001302) Components of the system are intended to replace the pro
- Manufacturer
- Zimmer Biomet, Inc.
- Affected units
- 3,350
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 (4)
- a. Item No. 00585001201 (Lot Expiration Date Before 07/31/2026)
- b. Item No. 00585001202 (Lot Expiration Date Before 07/31/2026)
- c. Item No. 00585001301 (Lot Expiration Date Before 08/31/2026)
- d. Item No. 00585001302 (Lot Expiration Date Before 07/31/2026)
Distribution
Part of a larger recall action
This product is one of 2 recalled by Zimmer Biomet, 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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