Recall Z-1060-2018— Zimmer Biomet, Inc.
Class II · Terminated
Class II FDA medical device recall by Zimmer Biomet, Inc., initiated 2017-11-29, terminated 2020-04-02. It names 2 FDA 510(k) clearances: K071107, K070214. Product: 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).. Reason: 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..
- Recalling firm
- Zimmer Biomet, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-11-29
- Terminated
- 2020-04-02
- Firm location
- Warsaw, IN, United States
510(k) clearances named in this recall
2 on FDA's record- K071107 — GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM; NEX GEN COMPLETE KNEE SOLUTION CR-FLEX GENDER SOLUTIONS FEMALE FEMORAL COMPON
- K070214 — GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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).
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.