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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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.
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full 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.
Product Codes/Lot Numbers:
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.
Distribution:
Nationwide distribution
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0450-2016
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