Anspach Custom Shoulder Implant Recalled for Quality System Non-Compliance
The Anspach Effort, Inc. is recalling custom shoulder implants 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. The source text cites non-compliance with Quality System requirements but does not report any illnesses, injuries, or specific functional failures, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The specific product identified is the Anspach Shoulder Implant 011mm Rod, 20cm Long, Custom (Part Number: 98-0012; Serial Number: 201421). This device is intended to be used with Anspach Systems.
The recall was initiated because the units were not manufactured consistently with Quality System requirements. The source text does not specify the exact nature of the manufacturing inconsistencies or any specific defects.
The affected units were distributed worldwide, including to 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. The source text does not provide specific instructions for consumers or healthcare providers regarding the next steps for these implanted devices.
The recalled product
- Product
- ANSPACH***REF 98-0012***Shoulder Implant 011mm Rod, 20cm Long, Custom***Rx Only*** This device is intended to be used with Anspach Systems
- Manufacturer
- The Anspach Effort, Inc.
- Affected units
- 1
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: 98-0012
- Serial Number: 201421
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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