A.L.P.S. 4.0mm Cancellous Locking Screws intended for use in stabilization and fixation of fractures, revision procedure

FDA device recall Z-0450-2016 · posted 2015-12-18 · Terminated

Recall details

Recalling firm

Biomet, Inc.

Reason for recall

These screws have a single lead (instead of a triple lead) thread. The screw may sit proud in the plate, If the screw does not lock into the plate; the screw may back out. If the screw sits proud, soft tissue irritation may occur. If the screw does not lock into the plate and backs out, a revision surgery may be necessary.

Action taken

On 11/20/2015, URGENT MEDICAL DEVICE RECALL NOTICE notifications were sent to the affected distributors, hospital risk managers, and implanting surgeons via courier. Distributors were instructed to locate and return the affected product, hospitals to locate and discontinue use, and implanting surgeons to monitor patients. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Questions related to this notice should be directed to (574) 372-1570, Monday through Friday, 8 a.m. to 5 p.m.

Root cause

Process change control

Status

Terminated

Product code

HRS

Quantity affected

182, 965

Distribution

AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY,

Date initiated

2015-11-20

Date posted

2015-12-18

Date terminated

2016-09-08

Location

Warsaw, IN

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