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Femoral and Tibial Cutting Block Adapter Base. Brainlab… recallZ-0959-2017 · Brainlab AG · initiated Oct 27, 2016

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 Brainlab AG 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

Brainlab Knee Navigation System: Femoral and Tibial Cutting Block Adapter Base with specific serial numbers might contain parts made from incorrect material and therefore not be suitable for reprocessing

FDA root cause category: Mixed-up of materials/components

What the company is doing

The firm sent out a FIELD SAFETY NOTICE / PRODUCT NOTIFICATION letter via e-mail to all affected customers describing the reason for the recall as well as actions that needed to be taken. User Corrective Action: Affected customers are asked to identify all Femoral and Tibial Cutting Block Adapter Bases with serial numbers ranging from 1267114001 1267114070 and with serial number 1308615032, and remove them from clinical use in your hospital. Affected customers are not required to return the affected devices to Brainlab. Instead they are asked to dispose them according to their local regulations. Customers will be provided with a replacement accordingly. Note regarding the serial numbers/lot numbers listed in the Field Safety Notice / Product Notification CAPA- 20160914-001734: In regard to the potentially affected serial number range 1308615001 1308615045, the Field Safety Notice / Product Notification CAPA-20160914 001734 lists only one specific serial number/lot number (1308615032), since only this specific item had actually been distributed to a customer. The remaining items were still on stock when the issue was detected and are no longer distributed by Brainlab (these potentially affected items have been blocked from distribution).

Recall details

Recall number
Z-0959-2017
Status
Terminated
Initiated by the company
Oct 27, 2016
Recalling firm
Brainlab AG
Quantity
29 units
Product code
OLO
FDA submissions
K102990
Distribution
US Consignees located in the following states: New York, Wisconsin, Oklahoma and District of Columbia.***Foreign Conisgnees located in the following countries: Australia; Belarus; Germany; India; Japan; Malaysia; Singapore; Switzerland; United Arab Emirates and United Kingdom.

Product description

Femoral and Tibial Cutting Block Adapter Base. Brainlab knee, BrainLAB Image Guided Surgery System / Instrument, Stereotaxic

Code information (models, lots, serial numbers)

Model/Catalog Number: 41888-04  Description: FEM&TIB CUT BLOCK ADP "UNIVERSAL" BASE1  Model/Catalog Number:41866-77A Description: FEM&TIB CUT BLOCK ADAPTER KIT UNIV  Model/Catalog Number: 99700-43  Description: IGS INSTRUMENTATION  UDI: GTIN 04056481002626  Serial numbers/lot numbers: - 1267114001 1267114070 - 1308615001 1308615045

Devices named in this recall

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

Other devices under the same FDA submission

1 device cleared under K102990 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

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