Recall Z-2321-2020— Biomet
Class II · Terminated
Class II FDA medical device recall by Biomet, initiated 2020-05-14, terminated 2021-04-08. It names one FDA 510(k) clearance: K143697. Product: A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM HIGH PLATE LEFT 14 HOLE 234MM, Item Number: 110030309 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.. Reason: Distributed to the field without having completed design history files or design transfer activities.
- Recalling firm
- Biomet
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-05-14
- Terminated
- 2021-04-08
- Firm location
- Miami, FL, 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
A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM HIGH PLATE LEFT 14 HOLE 234MM, Item Number: 110030309 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.
Reason for recall
Distributed to the field without having completed design history files or design transfer activities
Data sourced from openFDA. This site is unofficial and independent of the FDA.