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)

Medical devices

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)

Medical devices

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)

Medical devices

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)

Medical devices

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)

Medical devices

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)

Medical devices

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)

Medical devices

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)

Medical devices

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)

Medical devices

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)

Medical devices

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)

Medical devices

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)

Medical devices

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)

Medical devices

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)

Medical devices

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)

Medical devices

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)

Medical devices

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)

Medical devices

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)

Medical devices

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)

Medical devices

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)

Medical devices

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)

Medical devices

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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