Zimmer Biomet, Inc. recalls GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM GENDER SOLUTIONS FEMALE (GSF) FEMORAL COMPONENT NONPOROUS¿ N-K FLX GSF NP FEM…

Recall date

November 29, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1060-2018

FDA classification

Class II

Brand / firm

Zimmer Biomet, Inc.

Sold / distributed

Worldwide Distribution: US (nationwide) and countries of: Argentina, Australia, Brazil, Bolivia, Canada, Chile, China, Colombia, Ecuador, El Salvador, India, Japan, Malaysia, Mexico, Netherlands, New Zealand, Nicaragua, Panama, Seoul-Korea, Singapore, Taiwan, Thailand, and UAE.

Why it was recalled

The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM GENDER SOLUTIONS FEMALE (GSF) FEMORAL COMPONENT NONPOROUS¿ N-K FLX GSF NP FEM SZ 0 RT N-K FLX GSF NP FEM SZ 4 LT N-K FLX GSF NP FEM SZ 4 RT Components with CSTi porous coating are indicated for uncemented or cemented use in skeletally mature individuals with intact medial and lateral collateral ligaments undergoing primary surgery for rehabilitating knees damaged as a result of Noninflammatory Degenerative Joint Disease (NIDJD) or Inflammatory Joint Disease (IJD).