Recall archive
245 recalls · page 8 of 11
Reported Jan 13, 2016
BIOMET 3i, PROVIDE PROTECTION CAP, Catalog # PPC484, PPC485, PPC654, and PPC655 BIOMET 3i Restorative Products are…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Biomet 3i, LLC
Matched: Brand · Product · Product details — Inadequate biocompatibility testing.
3 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 6, 2016
Radiographic Transparency for Certain and External Connection Tapered Implants. Images that assist with measurements…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Biomet 3i, LLC
Matched: Brand — Images contained within radiographic transparency ART 1036 are undersized.
FDA (openFDA device enforcement)
Reported Dec 30, 2015
A.L.P.S. 4.0mm Cancellous Locking Screws intended for use in stabilization and fixation of fractures, revision…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Biomet, Inc.
Matched: Brand — 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;…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 18, 2015
Biomet 3i Narrow Right Angle Large Driver Tip (Hexed). Driver tips are attached to a surgical drilling unit to carry…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Biomet 3i, LLC
Matched: Brand · Product · Product details — The RASH3N, a hexed, abutment screw driver tip has been labeled and distributed as RASQ3N, a square, abutment screw driver tip. Additionally, the…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Nov 11, 2015
MaxAn 4.0mm and 4.5mm fixed screws, used in the MaxAn Anterior Cervical Plate System. The MaxAn Anterior Cervical Plate…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Biomet Spine, LLC
Matched: Brand — The packaging of 4.5 mm diameter MaxAn screws identifies/labels the screws as 4.0 mm diameter screws.
FDA (openFDA device enforcement)
Reported Oct 28, 2015
Neuro Combo Set Case The cases hold surgical instrumentation in place during handling and storage.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Biomet Microfixation, LLC
Matched: Brand — The lids on implant caddies within P/N 17-5000 and 19-5000 could not be opened by the user without application of undesirable/unexpected excessive…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Sep 23, 2015
UCLA Abutment Hexed Castable Cylinder 3.4mm Are accessories to endosseous dental implant to support a prosthetic device…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Biomet 3i, LLC
Matched: Brand — MUCC2, non-hexed, castable abutment cylinders, has been labeled and distributed as a MUCC1C, hexed, castable abutment cylinders for this one lot only.
FDA (openFDA device enforcement)
Reported Sep 16, 2015
Biomet Parsippany, NJ. 4 0 MM X 14 MM Variable Screw C-Tek Maxan Anterior Cervical Plate System. Lot 375440.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Biomet Spine, LLC
Matched: Brand · Product · Product details — Some of P/N 14-521614B Lot 375440 was mislabeled as P/N 14-521614 Lot 375440.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Sep 9, 2015
Vision RingLoc Shell 50 mm Size 23. Hip joint replacement prosthesis.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Biomet, Inc.
Matched: Brand — The device was assembled without screw hole plugs.
FDA (openFDA device enforcement)
Reported Jul 29, 2015
Polaris 4.75 TI Spinal System, 4.0 x 20 MM, Closed MAS, Closed Head Multiaxial Screw, Non-Sterile, Rx Only, REF…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Biomet Spine, LLC
Matched: Brand · Product details — Multiaxial screws may not meet internal requirements related to fatigue strength. Compression testing result and surface treatment are out of…
FDA (openFDA device enforcement)
Reported Jul 22, 2015
A.L.P.S., 3.5mm x 60 mm Cortical Locking Screw. Bone fixation screw
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Biomet, Inc.
Matched: Brand — Sterile packaging was not sealed. The implantation of an unsterile screw may lead to infection.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 15, 2015
A.L.P.S. Foot Locking Calcaneus Plate,Small-Right. Provides the orthopaedic surgeon a means of bone fixation and helps…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Biomet, Inc.
Matched: Brand — The thread location on one of the thread holes is offset from the axis of the predrill hole. The threads are too deep on one side and too shallow on…
FDA (openFDA device enforcement)
Reported Jul 8, 2015
Gentle Threads Interference Screw 10x25mm Round Head. An interference fixation screw for use in soft tissue…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Biomet, Inc.
Matched: Brand — Part Number: 905620 Lot: 824610 Gentle Threads Interference Screw 10x25mm Round Head is mixed with the Part Number: 905627 Lot: 753410 Gentle Threads…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jun 24, 2015
Vanguard M Unicondylar Tibial Trial For use during knee joint replacement.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Biomet, Inc.
Matched: Brand — The Left and Right orientation of the trial was incorrectly etched on one side. When the instrument is rotated about the axis of the handle 180…
FDA (openFDA device enforcement)
Reported Jun 17, 2015
The Optigun Ratchet is a hand-held cement gun for use with Optivac. The Optigun Ratchet is used to deliver bone cement…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Biomet France S.a.r.l.
Matched: Brand — The pin which maintains the knob button, may disconnect and become lost. This may result in a delay of surgery to obtain a new Optigun and…
FDA (openFDA device enforcement)
Reported Jun 17, 2015
Unilateral external fixation ankle clamp Product Usage: Unilateral external fixation for use treatment of bone…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Biomet, Inc.
Matched: Brand — Ankle clamp was assembled incorrectly; the offset of the pin to the pivot point is reversed. This prevents complete range of motion and if pushed too…
4 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 29, 2015
Lineum HF Torque Handle Limit (Lineum) Model Number 14-525035 P_roduct Usage: Designed to facilitate reconstruction of…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Biomet Spine, LLC
Matched: Brand · Reason for recall — Biomet is recalling the Lineum HF Torque Handle Limit (Lineum) and Torque Limiting Handle (Aspen/ Alpine) due to the supplier withdrawing it from the…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Apr 22, 2015
3i T3 Non-Platform Switched Tapered Implant Rx Only; 3.25 x 8.5 - 15.0 mm Dental Implants.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Biomet 3i, LLC
Matched: Brand — Endosseous Dental Implants in contact with a residual machine fluid caused the implants to be discolored.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 22, 2015
LOW PROFILE NON-LOCK SCREW; 2.7mm x 22 mm; REF 131227222; LOT RM105E. Provides the orthopaedic surgeon a means of bone…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Biomet, Inc.
Matched: Brand · Reason for recall — A Biomet investigation found that the Low Profile Non-Locking Screw 2.7mmx22mm screw (Part Number: 131227222 Lot: RM105E) was anodized green and…
FDA (openFDA device enforcement)
Reported Apr 8, 2015
ToggleLoc; fastener, fixation, non degradable, soft tissue; Artificial Ligament Fixation Device #7 PE Ziploop Extended…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Biomet, Inc.
Matched: Brand — The firm is recalling ToggleLocs and Ziploops manufactured in May and July of 2014 as they were not processed following a standard work process,…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Mar 4, 2015
Set Screw 5.5 mm Rod - Model #7703-1600. Product Usage: The titanium alloy set screw is used to seat a 5.5 mm titanium…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Biomet Spine, LLC
Matched: Brand · Product details · Reason for recall — Biomet Spine LLC is recalling the Set Screw 5.5 mm Rod due to the set screw being out of specification
FDA (openFDA device enforcement)
Reported Mar 4, 2015
Comprehensive Reverse Shoulder Glenosphere Mini Baseplate 25mm with Taper Adaptor, Part Number: 010000589 Lot: 527400
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Biomet, Inc.
Matched: Brand — The taper adaptor is missing from the packaging, which may result in a delay in surgery greater than 30 minutes.
FDA (openFDA device enforcement)
Reported Feb 25, 2015
Mallory Head 4 Finned Acetabular Shell 50 mm, PN 13-104150, hip prosthesis component (Ringloc)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Biomet, Inc.
Matched: Brand · Reason for recall — Biomet recalled the Mallory Head 4 Finned Acetabular Shell 50mm (Lot 364600) and Ringloc + Acetabular Shell Limited Hole Finned 52 mm (Lot 427840)…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Feb 18, 2015
Timberline Cranial Caudal and Posterior Blades, 40 - 180mm Model # 8734-2XXX, 8734-5XXX is a reusable device provided…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Biomet Spine, LLC
Matched: Brand · Reason for recall — Biomet Spine, LLC is recalling the Timberline Cranial Caudal and Posterior Blades, 40-180mm due to oversize of the set screw hex feature.
1 more product in this recall
FDA (openFDA device enforcement)
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