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AFFIXUSHIP FRACTURE NAIL - LEFT recallZ-0437-2018 · Zimmer Biomet, Inc. · initiated Aug 7, 2017

Terminated

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Zimmer Biomet, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was 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.

FDA root cause category: Process change control

What the company is doing

Customers were notified via FedEx and/or email on approximately 08/07/2017. Instructions include ensure appropriate personnel are notified of the recall, locate and quarantine affected product in inventory, complete and return the Certification of Acknowledgement, return all affected product, and provide the names of hospitals or customers that would have received this product if further distributed.

Recall details

Recall number
Z-0437-2018
Status
Terminated
Initiated by the company
Aug 7, 2017
Recalling firm
Zimmer Biomet, Inc.
Quantity
638 units
Product code
HSB
FDA submissions
K100238
Distribution
US nationwide distribution. Also Portugal and the Netherlands.

Product description

Affixus Hip Fracture Nail, LH 130 DEG 11MM X 420MM

Code information (models, lots, serial numbers)

Item No. 814611420; Lot No. (Exp. Date) UDI: 535690 (05/30/2027) UDI (01)00887868039843 (17)270530 (10)535690

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

88 devices cleared under K100238 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 78763).

Sources and updates

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