Affixus Hip Fracture Nail recall
Affixus Hip Fracture Nail, RH 125 DEG 9MM X 320MM
Why was Affixus Hip Fracture Nail recalled?
During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.
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?
Item No. 814309320; Lot No. (Exp. Date) UDI: 669850 (06/15/2027) UDI (01)00887868038006 (17)270615 (10)669850; 737670 (06/14/2027) UDI (01)00887868038006 (17)270614 (10)737670
- Product
- Affixus Hip Fracture Nail, RH 125 DEG 9MM X 320MM
- Recalling firm
- Zimmer Biomet, Inc.
- Quantity
- 638 units
- Distribution
- US nationwide distribution. Also Portugal and the Netherlands.
- Recall date
- February 7, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)