Recall archive
245 recalls · page 9 of 11
Reported Jan 21, 2015
Timberline Anchored Lateral Variable Retractable Sleeve LITPCR8600-2101-07, Model No. 86300204 Timberline Anchored…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Biomet Spine, LLC
Matched: Brand — The inner diameter of the Sleeve shaft is undersized, resulting in interference fit when inserting the Anchored Lateral Straight Retractable Awl or…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 24, 2014
Device Brand Name: Sirius Polish Cemented Stem 34B Device Classification Name: prosthesis, hip, semi-constrained,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Biomet, Inc.
Matched: Brand · Product details · Reason for recall — After receiving a complaint, Biomet Orthopedic Inc., conducted an investigation which determined that the following parts were mixed up prior to…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Dec 17, 2014
Total Temporomandibular Joint Replacement System- 45mm Lft Narrow Ti Mand
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Biomet Microfixation, LLC
Matched: Brand — Laser etching on the parts is wider and deeper than the conditions previously validated.
13 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 26, 2014
LANX, REF, PCR8XXX-XXX, LOT, RXONLY. Packaged within aluminum sterilization case. Product Usage: The Durango implant is…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Biomet Spine LLC.
Matched: Brand · Reason for recall — Biomet Spine, LLC. announces voluntary recall of Durango Anchored ALIF Plate due to the set screw component potentially becoming dislodged from the…
FDA (openFDA device enforcement)
Reported Oct 22, 2014
Discovery Elbow Humeral Trial Product Usage: Biomet manufactures a variety of elbow joint replacement prostheses…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Biomet, Inc.
Matched: Brand · Product · Product details — An investigation identified that the product was incorrectly manufactured as a left humeral trial but is etched as a right humeral trial.
FDA (openFDA device enforcement)
Reported Oct 15, 2014
Compress Face Reamer Product Usage: Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Biomet, Inc.
Matched: Brand — Investigation determined that units supplied were missing the 4x21 degree helix angle.
3 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 17, 2014
BIOMET 3i Certain Bellatek Encode Healing Abutment Biomet 3i Healing abutments are temporary abutments indicated for…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Biomet 3i, LLC
Matched: Brand · Product · Product details — Identifiers on the label are correct but the label has the incorrect color coding.
FDA (openFDA device enforcement)
Reported Sep 10, 2014
Biomet Microfixation Temporomandibular Joint (TMJ) Patient Matched Left Fossa Part# CP751506 The Total…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Biomet Microfixation, LLC
Matched: Brand · Product · Product details — Product mix occurred prior to final package and labeling process.
FDA (openFDA device enforcement)
Reported Aug 27, 2014
Vanguard 360 Femoral Boss Reamer, Label: REF 32-488474 VANGUARD 360 1NSTRUMENT FEMORAL BOSS REAMER NON-STERILE, BIOMET…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Biomet, Inc.
Matched: Brand · Product · Product details — The Vanguard 360 Femoral Boss Reamers were manufactured oversized to the print. The instrument may not fit into the mating component.
FDA (openFDA device enforcement)
Reported Aug 20, 2014
Device Brand Name: Distal Radius Fracture Repair System Device Classification Name: Plate, Fixation, Bone Device Common…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Biomet, Inc.
Matched: Brand — The firm received complaints indicating that the drill guide becomes stuck in the jig. The drill guide can be placed in the jig about halfway before…
FDA (openFDA device enforcement)
Reported Jul 2, 2014
DISCOVERY ELBOW prosthesis, 4 MM X 100 MM RIGHT HUMERAL FLANGED I BOND COAT Tl 6AL 4V ALLOY. Elbow joint replacement…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Biomet, Inc.
Matched: Brand — Surface finish is different than specified. The implant has 30 grit blast on the exterior of the flange when the print calls for the glass bead…
FDA (openFDA device enforcement)
Reported Jun 25, 2014
EZPass Suture Retriever, Nitinol, Single Pack, Part number 10007380. Orthopedic Manual Surgical Instrument, Sterile,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Biomet, Inc.
Matched: Brand — The nitinol wire or monofilament may buckle within the EZPass Suture Passer and become kinked making the wire/monofilament difficult to use.
4 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 25, 2014
Biomet Spine, Cypher MIS Screw Inserter, Catalog number 14-501669, instrument for Spinal Screw Fixation System.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ebi, LLC
Matched: Product · Product details — The Cypher MIS Screw Inserter may exhibit an increased rate of instrument tip failure.
FDA (openFDA device enforcement)
Reported May 21, 2014
ExploR 7x26mm Modular Radial Stem, Catalog number 11-210062. Elbow prosthesis orthopedic implant.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Biomet, Inc.
Matched: Brand — This lot of the ExploR Modular Radial Stem may be missing the wedge ramp threads. If the wedge ramp threads are missing from the stem, the likelihood…
FDA (openFDA device enforcement)
Reported Apr 23, 2014
BIOMET 3i Endosseous Dental Implant.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Biomet 3i, LLC
Matched: Brand · Product · Product details — Due to residual machining fluid identified by discoloration (darker in appearance) on the external dental implant surface.
FDA (openFDA device enforcement)
Reported Mar 26, 2014
Dental Abutment labeled in part: "4555 Riverside Drive Palm Beach Gardens, FL 33410 USA 1-800-342-5454***EDAZ , EDAZx…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Biomet 3i, LLC
Matched: Brand · Product details · Reason for recall — Reports relating to Biomet 3i's BellaTek Zirconia Dental Abutment fractures were received.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Mar 26, 2014
Part 475620 Intramedullary Bone Saw CAM Assembly Size 12mm, A unique and exclusive clinical instrument used to correct…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Biomet, Inc.
Matched: Brand — Incorrect labeling on specific lots of the Intramedullary Bone Saw.The Saw Blade Assembly was identified as CAM Assembly.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Mar 19, 2014
Navigator Surgical Kit Product Usage: Molded plastic tray used in holding various dental instruments for autoclave…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Biomet 3i, LLC
Matched: Brand — During recent revised sterilization validation testing, the included surgical trays did not meet the Sterility Assurance Level required.
4 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 22, 2014
Locking Cortical Screw 3.5mmX38mm REF 8161-35-038
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Biomet, Inc.
Matched: Brand — 3.5mmx38mm Locking Cortical Screw, implants are being recalled since an investigation identified that a 3.5mmx28mm Cortical Locking Screw is labeled…
FDA (openFDA device enforcement)
Reported Jan 1, 2014
G7 Acetabular Screw 6.5mmx35mm Part Number: 010001000
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Biomet, Inc.
Matched: Brand — Investigation identified that the outer label, inner label, and patient label all have the incorrect diameter size of 10.5mm. The screw is actually a…
FDA (openFDA device enforcement)
Reported Dec 25, 2013
outer box: Ref 906768, CurvTek Eye Needle 22 MM X-large Stainless Steel, Single Use Gamma Sterilized, Rx inner…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Biomet, Inc.
Matched: Brand — Inner label of PN: 906768 Lot: 055450 CurvTek Eye Needle 22mm X-Large states incorrectly PN: 906760 7mm Medium.
FDA (openFDA device enforcement)
Reported Dec 4, 2013
REF 200068 Security (TM) Enclosed Carpal Tunnel System Blade ( Single) ABS /Stainless Steel Sterile Device, Single Use…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Biomet, Inc.
Matched: Brand — Security Blades were manufactured oversized and potentially won't advance or may be difficult to advance through the mating Security Clip.
FDA (openFDA device enforcement)
Reported Dec 4, 2013
Shortened Plug Driver; Low Volume Specialty Device; Qty:1; Rx Only; Non Sterile; Biomet Spine, Parsippany, NJ 07054 The…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ebi, LLC
Matched: Product · Product details · Reason for recall — Biomet received a complaint on 5/20/2013 reporting that the tip of the instrument sheared off during a removal case.
FDA (openFDA device enforcement)
Reported Nov 27, 2013
Juggerknotless Drill Bit, REF 110003173, Sterile, Single Use Product Usage: The Juggerknotless Soft Anchors are…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Biomet, Inc.
Matched: Brand — Investigation identified that the design of the drill bit may make the suture anchor difficult to insert into the bone. The implant may skip across…
FDA (openFDA device enforcement)
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