Integra CRW Precision Arc (CRWPRECISE), CRW Arc System (CRWASL), HRAIM Head Ring Assembly with Intubation Mounts The CRW

FDA device recall Z-2428-2012 · posted 2012-09-20 · Terminated

Recall details

Recalling firm

Integra LifeSciences Corporation

Reason for recall

T-handle screw is used on a complementary product to the CRW, the Integra HRAIM, which is the CT-compatible intubation Head Ring Assembly. When the T-handle on the HRAIM intubation hoop is tightened, the T-handle could stop in a vertical position that prevents the CRWPRECISE and certain models of the CRW-ASL from seating properly on the head ring although it appears to be fully seated

Action taken

The firm, Integra, sent an "URGENT: VOLUNTARY MEDICAL DEVICE RECALL NOTIFICATION" dated August 10, 2012 to US & Canada consignees/customers via traceable courier service and Non-US & Non-Canada consignees/customers - through written notification delivered either by traceable courier, email, facsimile, or through a directed visit by an Integra Sales Representative. The notification describes the product, problem and actions to be taken. The Integra sales representative will replace the screws according to the attached rework instructions. If for some reason it is not possible to replace the screws during the visit, the sales representative will leave the screws and customers can then replace them by following the attached rework instructions and discard the old screws immediately after replacement. The customers were instructed to complete and return the Product Recall Acknowledgement Form via the sales representatives visit; fax at 1-609-750-7999 or email to: csnirecalls@integralife.com and include the number of devices to be identified and replaced . Note:The T -Handle screws that are replaced will be disposed of at the consignee's/customers location. Please feel free to contact our service hotline at 888-772-7378 should you have any additional questions.

Root cause

Device Design

Status

Terminated

Product code

HAW

Quantity affected

175 units

Distribution

Worldwide distribution: USA (Nationwide) and countries of: Argentina, Australia, Belgium, Canada, China, Czec, Denmark, France, Hong Kong, Hungary, Italy, Japan, Malaysia, Philippines, Singapore, Spai

Date initiated

2012-08-09

Date posted

2012-09-20

Date terminated

2014-03-26

Location

Plainsboro, NJ

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