Recall Z-1055-2018— 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: K942263, K880155. Product: FEM PRC LT M/RT L SML FEM PRC RT M/LT L SML FEM PRC LT M/RT L SML+ FEM PRC RT M/LT L SML+ FEM PRC LT M/RT L REG FEM PRC RT M/LT L REG FEM PRC LT M/RT L REG+ FEM PRC RT M/LT L REG+ FEM PRC LT M/RT L LGE FEM PRC RT M/LT L LGE FEM PRC LT M/RT L LGE+ FEM PRC RT M/LT L LGE+ " These devices are indicated for patients with: - Painful and/or disabling knee joints due to osteoarthritis or traumatic arthritis. - Previous tibial condyle or plateau fractures with loss of anatomy or function. - Varus or valgus deformities. - Revision of previous arthroplasty procedures. " These devices are indicated for cemented use only. " The Zimmer Unicompartmental Knee System is designed for use when load bearing ROM is expected to be less than or equal to 155 degrees.. 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- K942263 — MILLER/GALANTE PRECOAT UNICOMPARTMENTAL KNEE SYSTEM
- K880155 — MILLER/GALANTE PRECOAT UNICOMPARTMENTAL KNEE
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
FEM PRC LT M/RT L SML FEM PRC RT M/LT L SML FEM PRC LT M/RT L SML+ FEM PRC RT M/LT L SML+ FEM PRC LT M/RT L REG FEM PRC RT M/LT L REG FEM PRC LT M/RT L REG+ FEM PRC RT M/LT L REG+ FEM PRC LT M/RT L LGE FEM PRC RT M/LT L LGE FEM PRC LT M/RT L LGE+ FEM PRC RT M/LT L LGE+ " These devices are indicated for patients with: - Painful and/or disabling knee joints due to osteoarthritis or traumatic arthritis. - Previous tibial condyle or plateau fractures with loss of anatomy or function. - Varus or valgus deformities. - Revision of previous arthroplasty procedures. " These devices are indicated for cemented use only. " The Zimmer Unicompartmental Knee System is designed for use when load bearing ROM is expected to be less than or equal to 155 degrees.
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.