Smith & Nephew Recalls Legion AP Cutting Blocks Due to Design Defect
Smith & Nephew is recalling specific lots of LEGION AP Cutting Blocks because they were manufactured with an oversize green plunger hole, failing to meet design specifications.
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, and the source text does not report any injuries, illnesses, or deaths, indicating a theoretical risk of harm rather than a confirmed adverse event.
Plain-English summary
Smith & Nephew, Inc. is recalling 59 units of LEGION AP Cutting Blocks (Sizes 4, 6, 7, and 8) under FDA recall number Z-0878-2020. The affected orthopaedic manual surgical instruments were distributed in the United States (IA, NC, PA, TN) and internationally (CH, BE, GB, AE, CN, DE, NL, BR, FR).
The recall was initiated because multiple lots of these cutting blocks were manufactured with an oversize green plunger hole. As a result, the devices do not meet their intended design specifications.
Healthcare facilities and distributors should stop using the affected units and contact Smith & Nephew for instructions on how to return or dispose of the products.
The recalled product
- Product
- LEGION AP Cutting Block Size 4, REF 71434409; LEGION AP Cutting Block Size 6, REF 71434411; LEGION AP Cutting Block Size 7, REF 71434412; LEGION AP Cutting Block Size 8, REF 71434413. (Orthopaedic manual surgical instrument).
- Manufacturer
- Smith & Nephew, Inc.
- Hazard
- Affected units
- 59
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 (19)
- LEGION AP Cutting Block Size 4
- Product Number 71434409
- Lot Numbers: 17LM05399
- 17LM07852
- 17LM07852A
- LEGION AP Cutting Block Size 6
- Product Number 71434411
- Lot Numbers: 17LM05397
- 17LM05398
- 17LM07849
- LEGION AP Cutting Block Size 7
- Product Number 71434412
- Lot Numbers: 17LM01746
- 17LM05390
- 17LM05394
- 17LM07851
- LEGION AP Cutting Block Size 8
- Product Number 71434413
- Lot Number: 17LM08442.
Distribution
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