—#142250

Product

A.L.P.S. 4.0mm Cancellous Locking Screws intended for use in stabilization and fixation of fractures, revision procedures, fusions, reconstructions (osteotomy) and non-unions of the bones.

FDA product code: HRS — Plate, Fixation, Bone
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K072083, K072832, K082300, K111663
Affected lot / code info: Part number and size (non-sterile) 816140010, 4.0X10MM; 816140012, 4.0X12MM; 816140014, 4.0X14MM; 816140016, 4.0X16MM; 816140018, 4.0X18MM; 816140020, 4.0X20MM; 816140022, 4.0X22MM; 816140024, 4.0X24MM; 816140026, 4.0X26MM; 816140028, 4.0X28MM; 816140030, 4.0X30MM; 816140032, 4.0X32MM; 816140034, 4.0X34MM; 816140036, 4.0X36MM; 816140038, 4.0X38MM; 816140040, 4.0X40MM; 816140042, 4.0X42MM; 816140044, 4.0X44MM; 816140046, 4.0X46MM; 816140048, 4.0X48MM; 816140050, 4.0X50MM; 816140055, 4.0X55MM; 816140060, 4.0X60MM; 816140065, 4.0X65MM; 816140070, 4.0X70MM; 816140075, 4.0X75MM; 816140080, 4.0X80MM; 816140085, 4.0X85MM; 816140090, 4.0X90MM; 816140095, 4.0X95MM; 816140100, 4.0X100MM Part number and size (sterile) 856140010, 4.0X10MM; 856140012, 4.0X12MM; 856140014, 4.0X14MM; 856140016, 4.0X16MM; 856140018, 4.0X18MM; 856140020, 4.0X20MM; 856140022, 4.0X22MM; 856140024, 4.0X24MM; 856140026, 4.0X26MM; 856140028, 4.0X28MM; 856140030, 4.0X30MM; 856140032, 4.0X32MM; 856140034, 4.0X34MM; 856140036, 4.0X36MM; 856140038, 4.0X38MM; 856140040, 4.0X40MM; 856140042, 4.0X42MM; 856140044, 4.0X44MM; 856140046, 4.0X46MM; 856140048, 4.0X48MM; 856140050, 4.0X50MM; 856140055, 4.0X55MM; 856140060, 4.0X60MM; 856140065, 4.0X65MM; 856140070, 4.0X70MM. All lots manufactured between 06/01/08 and 06/01/15.

Why it was recalled

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.

Root cause (FDA determination)

Process change control

Action the firm took

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.

Recalling firm

Firm: Biomet, Inc.
Address: 56 E Bell Dr, Warsaw, Indiana 46582-6989

Distribution

Distribution pattern: 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, PR CHILE, COSTA RICA, NETHERLANDS, CANADA

Timeline

Recall initiated: 2015-11-20
Posted by FDA: 2015-12-18
Terminated: 2016-09-08
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #142250. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.