Zimmer Biomet Recalls Gentle Thread PLGA Interference Screws Due to Commingling
Zimmer Biomet is recalling 52 Gentle Thread PLGA Full Thread Interference Screws because they were commingled with a different size.
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, but the source text does not report any illnesses, injuries, or hospitalizations, and the hazard is a packaging/commingling issue rather than a direct biological or structural defect causing harm.
Plain-English summary
Zimmer Biomet, Inc. is recalling 52 units of the Gentle Thread PLGA Full Thread Interference Screw, 10x30mm (Item Number 905629). The recall was initiated because these products were commingled with the Gentle Thread PLGA Round Head, 7x20mm.
The affected products were distributed to the US states of Indiana and Tennessee, as well as to Australia, Chile, and the Netherlands. The specific lot number is 625450.
Consumers and healthcare providers should stop using the affected products and contact Zimmer Biomet for further instructions.
The recalled product
- Product
- Gentle Thread PLGA Full Thread Interference Screw, 10x30mm, Item Number 905629
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
- Affected units
- 52
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)
- Lot Number 625450
- UDI (1)00880304421066(17)221019(10)625450
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.
See all 2 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 · commingling
See all →- HighZimmer Femoral Nail Recall: Risk of Commingled Angle Versions
FDA (Devices) · 2021-06-09
- ModerateZimmer Biomet Recalls Commingled Gentle Thread PLGA Interference Screws
FDA (Devices) · 2018-09-26