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Terminated

Hand Controls for Operon D750, D752, D760, D820 and D850 The hand controls are used to operate OPERON surgical tables

FDA Recall Z-1488-2013 · Posted 2013-06-06

Recalling FirmBerchtold Corp.
Recall StatusTerminated
Product CodeGDC
Date Initiated2013-03-12
Date Terminated2017-05-08
Product Quantity3763

Reason for Recall

The firm received complaints for unintended movements.

Firm Action

Berchtold sent an Urgent Medical Device Recall letter in March 2013, to all customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were recommended to clean the affected product and use the instructions to reduce the possibility of unintended movements until the firm could replace the affected product. Customers with questions were advised to contact the Berchtold Operon Pendanct Recall Coordinator at 800-243-5135, or 843-569-6100, ext 306. For questions regarding this recall call 843-569-6133.

Root Cause

Device Design

Distribution Pattern

Nationwide Distribution

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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