Medline Unite Foot & Ankle Screw recall
MEDLINE UNITE FOOT & ANKLE Screw, Polyaxial Locking, Mini T8 (2.0x8mm), REF MMSL2008
Why was Medline Unite Foot & Ankle Screw recalled?
The recall is due to observed intra-operative screw failure. When pre-drilled with ¿1.3mm drill bit for ¿2.0mm screws and ¿1.6mm drill bit for ¿2.4mm we have observed screw failure due to excessive torque.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA 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?
GTIN 10193489120707, Lot Number 810304
- Product
- MEDLINE UNITE FOOT & ANKLE Screw, Polyaxial Locking, Mini T8 (2.0x8mm), REF MMSL2008
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Quantity
- 420 units
- Distribution
- US Nationwide distribution.
- Recall date
- February 8, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)