Z-0450-2016Class II

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

Name: Z-0450-2016 A.L.P.S. 4.0mm Cancellous Locking Screws intended for use in stabilization and fixation of fractures...
Creator: Biomet, Inc.
Published: 2015-11-20
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2015-11-20 / Terminated

FDA source

Biomet, Inc. began a recall of A.L.P.S. 4.0mm Cancellous Locking Screws intended for use in stabilization and fixation of fractures, revision procedures, fusions, reconstructions (osteotomy)... on 2015-11-20. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0450-2016
Classification: Class II
Status: Terminated
Initiated: 2015-11-20
Posted: 2015-12-18
Terminated: 2016-09-08
Recalling firm: Zimmer GmbH
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.
Product code: HRS Plate, Fixation, Bone
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.
FDA root cause: Process change control
Action: 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.
Quantity in commerce: 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
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0450-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0450-2016	Class II	Terminated	Voluntary: Firm initiated	2015-12-30	2015-12-18

Product code HRS

Process control is the most common named cause of a device recall11 SEP 2026 / by Medical Device Manufacturing

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)