Anspach 8 mm Coarse Headless Screw Recall for Quality System Non-Compliance
The Anspach Effort, Inc. is recalling 8 mm Coarse Headless Screws because they were not manufactured consistently with Quality System requirements.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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. The hazard is a manufacturing quality issue without reported harm, fitting the criteria for a moderate severity score.
Plain-English summary
The Anspach Effort, Inc. is recalling its Anspach Custom Devices, specifically the 8 mm Coarse Headless Screw with Driver (Part Number 98-0022, Serial Number 2000040). The recall was initiated because the units were not manufactured consistently with Quality System requirements.
The affected devices were distributed worldwide, including to specific states in the United States and internationally to Canada, Japan, Hungary, Korea, and Sweden. The source text does not specify the number of units affected or report any illnesses or injuries associated with the use of these devices.
Healthcare providers and patients should stop using the affected screws and contact The Anspach Effort, Inc. for further instructions on how to return or replace the devices.
The recalled product
- Product
- ANSPACH***REF 98-0022***8 mm Coarse Headless Screw with Driver***Rx Only*** This device is intended to be used with Anspach Systems
- Manufacturer
- The Anspach Effort, Inc.
- Affected units
- 2
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)
- Part Number 98-0022. Serial Number: 2000040
Distribution
Part of a larger recall action
This product is one of 45 recalled by The Anspach Effort, 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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