Titanium SURFIX ALPHA SCREWS, a component of the Newdeal Hallu Lock Plate System. Surfix Alpha Variable angle locking sy

FDA device recall Z-1147-2012 · posted 2012-03-02 · Terminated

Recall details

Recalling firm

Integra LifeSciences Corp.

Reason for recall

Manufacturing error. The part number which corresponds to the length dimension of : 14 mm. was incorrectly etched on to screws with the actual measurement of: 12 mm.

Action taken

Integra contacted the Sales Representatives and All USERS on December 21, 2011, with a 'SUBJECT: MEDICAL DEVICE RECALL' letter. The letter was sent via FedEx and/or E-mail. The letter describes the product, problem, and the actions to be taken by the customers and the firm. The customers are instructed to immediately examine their inventories for the presence of the recalled product, and complete and return the attached, MEDICAL DEVICE RECALL ACKNOWLEDGMENT AND RETURN FORM via E-mail or FAX #1-609-0750-7999. Any questions concerning the recall document are to be addressed to the customers' regional managers or to the E-mail address and/or telephone number provided on the recall notification.

Root cause

Error in labeling

Status

Terminated

Product code

HRS

Quantity affected

105 units

Distribution

Nationwide Distribution, USA - including the states of OH, FL, WI, CT, OK, TN, OR, ID, CA, PA, MD, VA, FL, MS, NJ, LA, IA, GA, AL, MA, NY, MN, TN, IL, AR, NE, AZ, MI, WA, OR, NC, KY, MO, UT, NV, IN, S

Date initiated

2011-12-21

Date posted

2012-03-02

Date terminated

2013-02-19

Location

Plainsboro, NJ

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