PlainRecalls
FDA Devices Moderate Class II Ongoing

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).

Reported: February 5, 2020 Initiated: December 16, 2019 #Z-0878-2020

Product Description

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).

Reason for Recall

Multiple lots of LEGION AP Femoral Cutting Blocks were manufactured with an oversize green plunger hole and therefore do not meet their design specifications.

Details

Recalling Firm
Smith & Nephew, Inc.
Units Affected
59 units
Distribution
USA: IA, NC, PA, TN. Int'l: CH, BE, GB, AE, CN, DE, NL, BR, FR.
Location
Memphis, TN

Frequently Asked Questions

What product was recalled?
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).. Recalled by Smith & Nephew, Inc.. Units affected: 59 units.
Why was this product recalled?
Multiple lots of LEGION AP Femoral Cutting Blocks were manufactured with an oversize green plunger hole and therefore do not meet their design specifications.
Which agency issued this recall?
This recall was issued by the FDA Devices on February 5, 2020. Severity: Moderate. Recall number: Z-0878-2020.