FDAClass IIMarch 7, 2018

979195 Loaner Kit for femoral intramedullary nail. recall

979195 Loaner Kit for femoral intramedullary nail. Orthopedic instrument.

Why was 979195 Loaner Kit for femoral intramedullary nail. recalled?

Fracture of the bolt connecting the insertion guide to the intramedullary nail during insertion of the femoral nail.

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?

Finished Lot order: M370490 M354450 M321540 M975460 M639280 M426760 M629950 M629930 M073530 M073540 M073550 M073560 M073570 M073580 M073590 M073600 M073610 M627490 M656470 M656580 M656590 M656600 M656610 M656620 M656640 M656660 M966880 M967050 M967060 M967070 M980260 M980270 M508490 M508410 M508500 M508450 M508480 M508520 M508470 M508510 M508460

Product
979195 Loaner Kit for femoral intramedullary nail. Orthopedic instrument.
Recalling firm
Zimmer Biomet, Inc.
Quantity
337 total
Distribution
Distribution includes US Nationwide.
Recall date
March 7, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls