Recall Z-0837-2016— Zimmer Biomet, Inc.
Class II · Terminated
Class II FDA medical device recall by Zimmer Biomet, Inc., initiated 2016-01-11, terminated 2017-05-23. It names one FDA 510(k) clearance: K070695. Product: Gender PFJ FEMORAL COMP, prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer various sizes " Osteoarthritis, traumatic arthritis, polyarthritis, and/or severe chondrocalcinosis of the patellofemoral joint. The salvage of previously failed surgical attempts (e.g., arthroscopy, lateral release, cartilage transplantation). History of patellar dislocation or patella fracture. Dysplasia-induced degeneration. This device is intended for cemented use only.". Reason: LDPE bag containing the implant adheres to the highly polished implant surface..
- Recalling firm
- Zimmer Biomet, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-01-11
- Terminated
- 2017-05-23
- Firm location
- Warsaw, IN, United States
510(k) clearances named in this recall
1 on FDA's recordK-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 PFJ FEMORAL COMP, prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer various sizes " Osteoarthritis, traumatic arthritis, polyarthritis, and/or severe chondrocalcinosis of the patellofemoral joint. The salvage of previously failed surgical attempts (e.g., arthroscopy, lateral release, cartilage transplantation). History of patellar dislocation or patella fracture. Dysplasia-induced degeneration. This device is intended for cemented use only."
Reason for recall
LDPE bag containing the implant adheres to the highly polished implant surface.
Data sourced from openFDA. This site is unofficial and independent of the FDA.