Zimmer Biomet Recalls Various Surgical Screws and Reamers
Zimmer Biomet is recalling various surgical screws and reamers because non-highly polished implants may adhere to the LDPE bag.
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, and the hazard involves packaging adherence rather than a direct, high-risk biological or structural failure, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Zimmer Biomet, Inc. is recalling various surgical instruments, specifically screws and reamers, under recall number Z-0322-2020. The recall involves 5,459,583 total devices that were distributed nationwide. The affected products include specific item numbers such as 00579104100, 00579104200, and 00579104300, among others. All affected products were manufactured prior to January 2014.
The recall is being conducted because non-highly polished implants may adhere to the LDPE bag, which was the previous packaging configuration. This issue could potentially affect the handling or integrity of the surgical instruments during use. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Healthcare providers and facilities that have received these specific surgical instruments should stop using them and contact Zimmer Biomet for further instructions on how to return or dispose of the affected devices. Consumers are not directly affected as these are professional medical devices used in surgical settings.
The recalled product
- Product
- Various Surgical Instruments: Screws and Reamers, Item Nos. 00579104100 00579104200 00579104300 00579104400 00579105400 00597909526 00597909529 00597909532 00597909535 00597909538 00597909541 00597909546 00597909551 00598304027 00598304033 00598304048 00598304148
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
- Affected units
- 5,459,583
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 (1)
- All product manufactured prior to January 2014.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 41 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.
See all 41 products in this recall →Related recalls
Same manufacturer · Zimmer Biomet, Inc.
See all →- HighZimmer Biomet Recalls Spinal Rod Cutters Due to Fracture Risk
FDA (Devices) · 2020-12-30
- ModerateZimmer Biomet Recalls Polaris Spinal System Screws for Labeling Update
FDA (Devices) · 2020-12-23
- HighZimmer Biomet Recalls Hip Prosthesis Cups Due to Sterilant Biocompatibility Concerns
FDA (Devices) · 2020-11-11
- HighZimmer Biomet Recalls Hip Prosthesis Components Due to Sterilant Biocompatibility Concerns
FDA (Devices) · 2020-11-11
- HighZimmer Biomet Recalls Hip Prosthesis Component Due to Sterilant Concerns
FDA (Devices) · 2020-11-11
Same hazard · packaging adherence
See all →- ModerateZimmer Biomet Recalls Trabecular Metal Reverse Shoulder System Implants
FDA (Devices) · 2019-11-13
- ModerateZimmer Biomet Recalls Sidus Stem-Free Shoulder Humeral Head Implants
FDA (Devices) · 2019-11-13