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Minima S Instrument Set

LIMACORPORATE SPA · Model Trial Modular Neck · UDI-DI 08033390084970

MBL LPH KWZ KWY LZO JDI Prescription

510(k) clearances

1,004

Adverse events (1 deaths)

Recalls

114

Facilities

Description

Trial Modular Neck #1

Recalls

Date	Firm	Reason
2020-04-22	Smith & Nephew, Inc.	A manufacturing error resulted in out of specification R3 Acetabular Shells
2020-04-22	Smith & Nephew, Inc.	A manufacturing error resulted in out of specification R3 Acetabular Shells
2020-04-22	Smith & Nephew, Inc.	A manufacturing error resulted in out of specification R3 Acetabular Shells
2020-04-22	Smith & Nephew, Inc.	A manufacturing error resulted in out of specification R3 Acetabular Shells
2020-04-22	Smith & Nephew, Inc.	A manufacturing error resulted in out of specification R3 Acetabular Shells
2020-04-22	Smith & Nephew, Inc.	A manufacturing error resulted in out of specification R3 Acetabular Shells
2015-08-04	MicroPort Orthopedics, Inc.	Unexpected rate of postoperative fractures resulting in the need for revision surgery.
2014-01-23	Smith & Nephew Inc	Inner spherical radius of the shell is undersized.
2013-05-29	Smith & Nephew Inc	One batch of 60 mm 20o R3 XLPE liner may be laser etched and packaged as a 62 mm 20o liner and one batch of 62 mm 20o R3 XLPE liner may be laser etched and packaged as a 60 mm 20o
2013-05-29	Smith & Nephew Inc	One batch of 60 mm 20o R3 XLPE liner may be laser etched and packaged as a 62 mm 20o liner and one batch of 62 mm 20o R3 XLPE liner may be laser etched and packaged as a 60 mm 20o

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.