Recall archive
245 recalls · page 10 of 11
Reported Nov 27, 2013
Zeiss brand IOLMaster, Version 1-5, Biomicroscope, Slit-Lamp, AC-Powered, Product is manufactured by Carl Zeiss Meditec…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Carl Zeiss Meditec, Inc.
Matched: Product details — The user database delivered for download contained an erroneous value. Specifically the "aO" constant of the lens AMO Sensar AR40E is listed as "0.0"…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Nov 27, 2013
BIOMET Spine, 5.5 TI 5.5x50mm Translation Screw Polaris 5.5 TI Spinal System. Rx Only. Non-Sterile. Intended for…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ebi, LLC
Matched: Product · Product details · Reason for recall — Polaris Translation Screw Failures were recently reported to Biomet Spine. These failures are generally described as dissociation of the screw head…
FDA (openFDA device enforcement)
Reported Nov 20, 2013
Pneumatic Systems Operating Manual (part numbers 19-0005) utilized with the Pneumatic Motor Systems including: BlackMax…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.The Anspach Effort, Inc.
Matched: Reason for recall — Anspach Effort, Inc. Palm Beach Gardens, FL initiated a correction of its medical Device labeling for its Pneumatic Systems Operating Manual, Cutting…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 25, 2013
Osseotite 2 Certain Prevail 5mm(D)X 4.1mm (P) X X 11.5mm (L) Dental Implant Product Usage: Surgical placement in the…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Biomet 3i, LLC
Matched: Brand — One of the dental implants do not have the internal hex feature. One of the dental implants do not have the internal thread feature.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Sep 25, 2013
Cypher MIS Screw System, Biomet Spine Parsippany, NJ 07054. The Cypher MIS Screw System is a non-cervical spinal…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ebi, LLC
Matched: Product · Product details — Several complaints were reported to exhibit screw head splay in the Cypher MIS Screw System.
FDA (openFDA device enforcement)
Reported Sep 25, 2013
Sonogage EyeScan, A-Scan Biometer, Product Usage: A-Scan Biometer diagnostic device for measurement of axial eye length.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Sonogage Inc.
Matched: Product · Product details — During an FDA inspection on 7/15-26/2013, it was discovered that the firm lacked registration and 510(k) clearance for the device.
FDA (openFDA device enforcement)
Reported Aug 21, 2013
Biomet 3i Dental Implant, Parallel Walled 6mm (D) x 10mm (L)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Biomet 3i, LLC
Matched: Brand · Product · Product details — A small number of outer implant boxes may be mislabeled. The inner tray, containing the implant, is label correctly. This condition, if present and…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jul 17, 2013
REF 154200 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size A3 ARCOM UHMWPE / CO-CR-MO Alloy Only for use…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Biomet, Inc.
Matched: Brand · Reason for recall — Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing…
29 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 10, 2013
-Instratek Carpal Tunnel Release Blades, (1) Triangle Blade, (1) Hook Blade. REF R2056 - LOT 122279 -Instratek Carpal…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Surgical Instrument Service And Savings, Inc.
Matched: Product details — The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch.
21 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 26, 2013
Biomet Trauma Phoenix Retrograde Femoral Connecting Bolt Trauma Fixation Systems. Product Usage: The Phoenix Retrograde…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Biomet, Inc.
Matched: Brand · Product · Product details · Reason for recall — Biomet Trauma ("Biomet") has initiated a recall of Retrograde Femoral Connecting Bolt, which involves Part Number 14-442021. The connecting bolt has…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jun 12, 2013
Active Articulation E1. Intended for use with either primary or revision hip arthroplasty.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Biomet, Inc.
Matched: Brand · Reason for recall — Biomet is recalling Active Articulation E1 Hip Bearing implants. Biomet has initiated this action following an investigation which identified that…
FDA (openFDA device enforcement)
Reported Apr 24, 2013
REF 32-422760 Oxford Uni Knee System,Toffee Hammer, non-sterile, found in REF 32-422763 Oxford Mlcroplasty Knee System…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Biomet U.K., Ltd.
Matched: Brand — Investigation of complaints found excessive use of the instrument could result in cracking on the weld between the head and the handle, which could…
FDA (openFDA device enforcement)
Reported Mar 27, 2013
Biomet Spine Polaris 5.5 Button Lock Screw Inserter. Catalog Number 14-500178. The Polaris Spinal System is a…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ebi, LLC
Matched: Product · Product details — Increased risk of failure at the driver tip during screw insertion or removal.
FDA (openFDA device enforcement)
Reported Mar 20, 2013
REF S313152 Straight Acetabular Inserter Handle Ringloc non-sterile Orthopedic manual surgical instrument
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Biomet, Inc.
Matched: Brand — The Straight Ringloc Button Latch Inserter Handle may have been manufactured at the higher end of the tolerance causing interference with the Ringloc…
FDA (openFDA device enforcement)
Reported Feb 6, 2013
TUNNELOC ROUND HEAD INTERFERENCE SCREW 8MMX25MM Biomet Sports Medicine manufactures a variety of internal fixation…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Biomet, Inc.
Matched: Brand · Product · Product details — Thru hole at the tip of the screw is undersized.
FDA (openFDA device enforcement)
Reported Jan 16, 2013
PT113950 PT HYBRID Glenoid Post Regenerex porous titanium construct Sterile R Prosthesis, Shoulder, Semi-Constrained,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Biomet, Inc.
Matched: Brand · Reason for recall — Biomet is recalling Part Number PT-113950 PT Hybrid Glenoid Post, following an investigation which identified that the male thread of the post may be…
FDA (openFDA device enforcement)
Reported Dec 26, 2012
EBI XFIX DFS Rail System (Adult Rail Gradual Swivel Clamp). The Biomet Rail System consists of a unilateral external…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Biomet, Inc.
Matched: Brand · Product · Product details — It was reported that the number scale/graduation markings were missing on 14 pieces of the swivel clamp.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Dec 26, 2012
Biomet Polaris 5.5 Button Lock Screw Inserter. Catalog number 14-500178
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ebi, LLC
Matched: Product · Product details — Broken screw insertor hardness was measured and found to be below the acceptable limits.
FDA (openFDA device enforcement)
Reported Dec 12, 2012
OSS Reamer Sleeve REF132-472661 KNEE REAMER SLEEVE 8.0 THRU 12.5 STAINLESS STEEL The OSS Knee Reamer Sleeves are…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Biomet, Inc.
Matched: Brand · Reason for recall — Biomet has initiated this action following an investigation which identified that the thin shaft reamer may get stuck and not slide into the sleeve.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 5, 2012
Echo Bi-Metric Press-Fit Stems/Echo Bi-Metric 11mm x 135mm Collarless Porous Stem (Orthopedic Implant) Indications: 1)…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Biomet, Inc.
Matched: Brand — It was reported that the surgeon noticed that the Echo 11mm hip stem had an etching indicating it was 13mm stem.
FDA (openFDA device enforcement)
Reported Nov 28, 2012
Product is Full OSSEOTITE 2 Tapered Certain Implant, Model Number XIFNT413, and size 4 x 13 mm. The product is sterile.…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Biomet 3i, LLC
Matched: Brand · Reason for recall — Biomet 3i recalled Full OSSEOTITE 2 Tapered Certain Implant and Full OSSEOTITE Parallel Walled Certain Implant due to a manufacturing condition where…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Nov 28, 2012
Ranawat/Burnstein Acetabular Shell 54mm/Limited Holes/Porous Coated is a metallic, full-hemisphere, acetabular shell…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Biomet, Inc.
Matched: Brand — The color code on label conflicts with the liner size (liner size 24 should be green, not yellow)
FDA (openFDA device enforcement)
Reported Oct 31, 2012
Osseotite Tapered Certain Implant 5 X 10mm Model INT510 Biomet 3i Dental Implants are intended for surgical placement…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Biomet 3i, LLC
Matched: Brand · Product · Product details · Reason for recall — Biomet 3i recalled their Osseotite Tapered Certain Implant, Model # INT510 due to a small percentage of the devices are missing the internal…
FDA (openFDA device enforcement)
Reported Oct 10, 2012
Optilock 2.7 mm Screw Inserter. Intended Use: The OptiLock Upper Extremity Plating System is intended for fixation of…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Biomet, Inc.
Matched: Brand — Field complaints indicate that recent shipments of the 14-400795 and 36505 drivers do not properly mate ("lock") into some of the specified screw…
1 more product in this recall
FDA (openFDA device enforcement)
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