Anspach Recalls Arthroscopic Knotless Suture Anchors for Quality System Non-Compliance
The Anspach Effort, Inc. is recalling 100 units of Arthroscopic Knotless Suture Anchors 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, which typically indicates a temporary or medically reversible adverse health consequence. The source text cites a manufacturing quality system deviation without reporting specific injuries, illnesses, or fatalities, aligning with a Moderate severity rating for a precautionary quality control recall.
Plain-English summary
The Anspach Effort, Inc. is recalling 100 units of its Arthroscopic Knotless Suture Anchors. The recall was initiated because the units were not manufactured consistently with Quality System requirements.
The affected devices are identified by Part Numbers SP-4606-00 and SP-5002-00. Specific serial numbers involved in the recall include 200251, 200243, 200223, 200218, 200215, 200200, 200190, 200252, 200244, and 200222. These devices are intended for use with Anspach Systems.
The recalled products were distributed worldwide, including to specific U.S. states such as Alabama, California, Florida, Iowa, Illinois, Kentucky, Minnesota, Mississippi, North Carolina, Ohio, Oklahoma, Pennsylvania, Tennessee, and Texas. International distribution included Canada, Japan, Hungary, Korea, and Sweden. The source text does not specify instructions for consumers or healthcare providers regarding the handling of these devices.
The recalled product
- Product
- ANSPACH***Arthroscopic Knotless Suture Anchor***Rx Only*** This device is intended to be used with Anspach Systems
- Manufacturer
- The Anspach Effort, Inc.
- Category
- Medical Device — Orthopedic
- Affected units
- 100
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 (11)
- Part Number: SP-4606-00
- SP-5002-00. Serial Numbers: 200251
- 200243
- 200223
- 200218
- 200215
- 200200
- 200190
- 200252
- 200244
- 200222.
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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