A.L.P.S. 4.0mm Cancellous Locking Screws intended for recall
A.L.P.S. 4.0mm Cancellous Locking Screws intended for use in stabilization and fixation of fractures, revision procedures, fusions, reconstructions…
Why was A.L.P.S. 4.0mm Cancellous Locking Screws intended for 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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.
- Product
- A.L.P.S. 4.0mm Cancellous Locking Screws intended for use in stabilization and fixation of fractures, revision procedures, fusions, reconstructions…
- Recalling firm
- Biomet, Inc.
- Quantity
- 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, PR CHILE, COSTA RICA, NETHERLANDS, CANADA
- Recall date
- December 30, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)