fastener recall
fastener, fixation, nondegradable, soft tissue
Why was fastener recalled?
It was identified that the product was not assembled correctly causing the implant shaft to shift and fall out during the opening of the device, which potentially could break the device.
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 # 110019010 Lot #'s 017350 141990 142000 142020 167190 240720 240740 240770 257970 398710 398730 398740 398750 421780 421790 421800 465910 504120 813190 940370
- Product
- fastener, fixation, nondegradable, soft tissue
- Recalling firm
- Zimmer Biomet, Inc.
- Quantity
- 429 units
- Distribution
- TX, NC, FL, PA, IN, WI, VA, NY, NJ, AL, CT
- Recall date
- March 21, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)