A.L.P.S. 4.0mm Cancellous Locking Screws recallZ-0450-2016 · Biomet, Inc. · initiated Nov 20, 2015
Class II Terminated All recalls posted in December 2015
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Biomet, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
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.
FDA root cause category: Process change control
What the company is doing
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.
Recall details
- Recall number
- Z-0450-2016
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Nov 20, 2015
- Posted by the FDA
- Dec 18, 2015
- Recalling firm
- Biomet, Inc.
- Quantity
- 182, 965
- Product code
- HRS
- FDA submissions
- K072083, K072832, K082300, K111663
- 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
Product description
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.
Code information (models, lots, serial numbers)
Show the full code information (1k characters)
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.
Other devices under the same FDA submission
1 device cleared under K072083, K072832, K082300, K111663 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- A.L.P.S.® 8513-18-500Biomet Orthopedics, LLC · Plate, fixation, bone1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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