A.l.p.s. T15 LOW Profile Cortical Screw 3.5mm X 28mm recall
A.L.P.S. T15 LOW PROFILE CORTICAL SCREW 3.5mm x 28mm, Item Number: 110017628 - Product Usage: Intended for temporary internal fixation and…
Why was A.l.p.s. T15 LOW Profile Cortical Screw 3.5mm X 28mm recalled?
Distributed to the field without having completed design history files or design transfer activities
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot Number: J3835075 (01)00887868131769(17)260722(10)J3835075
- Product
- A.L.P.S. T15 LOW PROFILE CORTICAL SCREW 3.5mm x 28mm, Item Number: 110017628 - Product Usage: Intended for temporary internal fixation and…
- Recalling firm
- Biomet
- Quantity
- 15 OUS
- Distribution
- Worldwide distribution - US Nationwide distribution including in the states of NY, GA, FL, MO and the countries of Canada, AUSTRALIA, CHILE, CHINA, JAPAN, MALAYSIA, NETHERLANDS.
- Recall date
- June 17, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)