—#107345

Product

Titanium SURFIX ALPHA SCREWS, a component of the Newdeal Hallu Lock Plate System. Surfix Alpha Variable angle locking system exists in different diameters and lengths. The product can be sold as a replenishment part individually packaged sterile, or as one (1) unit which is kitted within an instrumentation tray at which point, the product is non-sterile until the tray in which it is kitted is sterilized a the designated facility. The product is indicated for use in fixation of fractures, osteotomies or arthrodesis of the first metatarso-phalangeal joint.

FDA product code: HRS — Plate, Fixation, Bone
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K083154
Affected lot / code info: Model #295214S, Part #295214SND, Batch #EGH9

Why it was recalled

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.

Root cause (FDA determination)

Error in labeling

Action the firm took

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.

Recalling firm

Firm: Integra LifeSciences Corp.
Address: 311 Enterprise Dr, Plainsboro, New Jersey 08536-3344

Distribution

Distribution pattern: 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, SC, CO and the countries of the United Kingdom, France, Switzerland, and Austria.

Timeline

Recall initiated: 2011-12-21
Posted by FDA: 2012-03-02
Terminated: 2013-02-19
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #107345. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.