Anspach 8 mm Coarse Threaded Headless Bone Screw Recalled for Quality Issues
The Anspach Effort, Inc. is recalling 10 units of 8 mm Coarse Threaded Headless Bone Screws because they were not manufactured consistently with Quality System requirements.
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 source text cites a manufacturing quality system deviation without reporting specific injuries, illnesses, or deaths. This aligns with the rubric for moderate severity involving low-risk contamination or voluntary precautionary recalls.
Plain-English summary
The Anspach Effort, Inc. is recalling 10 units of Anspach 8 mm Coarse Threaded Headless Bone Screws. The recall was initiated because the units were not manufactured consistently with Quality System requirements.
The affected devices are identified by Part Number 98-0029 and Serial Number 20000263. These medical devices are intended to be used with Anspach Systems and are prescription-only.
The recalled units were distributed worldwide, including in the United States (AL, CA, FL, IA, IL, KY, MN, MS, NC, OH, OK, PA, TN, TX) and internationally to Canada, Japan, Hungary, Korea, and Sweden. Healthcare providers and patients should contact The Anspach Effort, Inc. for further instructions regarding the return or replacement of these devices.
The recalled product
- Product
- ANSPACH***REF 98-0029***8 mm Coarse Threaded Headless Bone Screw***Rx Only*** This device is intended to be used with Anspach Systems
- Manufacturer
- The Anspach Effort, Inc.
- Affected units
- 10
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 Number 98-0029
- Serial Number: 20000263
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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