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Terminated

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 Recall Z-0450-2016 · Posted 2015-12-18

Recalling FirmBiomet, Inc.
Recall StatusTerminated
Product CodeHRS
Date Initiated2015-11-20
Date Terminated2016-09-08
Product Quantity182, 965

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.

Firm 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.

Root Cause

Process change control

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K111663TRAUMA INTERNAL FIXATION SYSTEMSDePuy Orthopaedics, Inc. · 2012-03-12K082300ANATOMIC LOCKING PLATING SYSTEMDePuy Orthopaedics, Inc. · 2009-02-18K072832ANTEROLATERAL AND MEDIAL LOCKING PLATING SYSTEMDePuy Orthopaedics, Inc. · 2007-12-14K072083SMALL FRAGMENT LOCKING PLATING SYSTEMDePuy Orthopaedics, Inc. · 2007-10-25

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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