ASSISTO Arm System Table-mounted self retaining instrument holder system consisting of stainless steel tubular, articula

FDA device recall Z-1061-2012 · posted 2012-02-19 · Terminated

Recall details

Recalling firm

Geomed Medizin-Technik Gmbh & Co.

Reason for recall

The product may fracture during surgical procedures.

Action taken

Geomed Medizin-Technik Product sent an Urgent Voluntary Medical Device Recall notification on December 9, 2012 and December 16, 2012 to affected customers. The letter identified the affected products, reason for recall and actions to be taken. Customers were instructed to (1) fill out the enclosed return form and fax back immediately at +49 (0)7461-935593, (2) return the affected products to the address provided, including the completed return form, (3) use the UPS account number 03710R provided to return the products free of charge and (4) immediately forward a copy of this recall notification to third parties to which you have distributed affected products. For questions and support, please contact Mr. Hanno Haug, VP -AMB at +49 (0)7461 9355-30 or by email: hhaug@geomed.de.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

GWG

Quantity affected

1,205 units

Distribution

Worldwide Distribution - USA (nationwide) including the countries of: Australia, Belgium, China, Denmark, Finland, France, Germany, Great Britain, India, Italy, Japan, Lebanon, Libya, Lithuania, Luxem

Date initiated

2011-12-16

Date posted

2012-02-19

Date terminated

2014-04-15

Location

Tuttlingen, Germany

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