Medacta Usa Inc recalls GMK Efficiency - GMK Sphere CR Insert Instrument Set Size 1
A Size 2 trial baseplate was assembled with Size 1 instrument sets.
Read the official notice →- Date
- 2022-06-15
- Country
- United States
- Brand
- Medacta
- Product
- GMK Efficiency - GMK Sphere CR Insert Instrument Set Size 1
- Classification
- Class II
- Units
- Distribution was made to AK, CA, CT, IN, MA, NJ, and PA. There was no…
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More Medacta recalls
- 2026-07-08
USMedacta Usa Inc recalls Short Monobloc Stem Broaches, Size/REF: 7/04.01.10.0970, 8/04.01.10.0971, 9/04.01.10.0972, 10/04.01.10.0973, 11/04.01.10.0974,…
Surgical instruments used during shoulder arthroplasty procedures does not progressively translate to replicate implant geometry, so the reaming guide and the stem reamer are positioned approximately 0.2 mm per size…
FDA · DeviceMedacta Usa IncUS Nationwide distribution in the states of CO, AR, IN, PA, UT, FL.Official notice →- 2023-04-26
- US
Medacta Usa Inc recalls MectaLIF ANTERIOR - Lag Plate Flush H10, REF 03.30.300, interbody fusion device
There is a potential for breakage of the small screw used to affix the anti-backout plate.
- 2022-12-14
- US
Medacta Usa Inc recalls NextAR Shoulder Surgical Technique, Shoulder NextAR RSA Platform, CT based computer-assisted surgical navigation platform used to perform…
A warning has been added to the Surgical Technique for NextAR Shoulder, advising verification of suitable patient conditions prior to placement of the NextAR Shoulder Target Holder: WARNING Target fixation requires…
Other drugs & medical recalls in the United States
- 2022-06-15
- US
NeuMoDx Molecular Inc recalls NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test Strip, Model No. 300900
There is a potential for reduced analytical sensitivity for samples in the 1x - 3x LOD range for Flu A, RSV, and SARS-CoV-2 targets. This may lead to false negative results, allowing ongoing transmission to others and…
FDA · DeviceNeuMoDx Molecular IncDomestic distribution to FL, NY, MD, PA, VA, MI, TN, NM. Foreign distribution…Official notice → - US
ROi CPS LLC recalls Regard Item Number: 800214007 Sterile GS00367 - GASTRO BYPASS - SPARTANBURG. CONMED Catalog No. 60-5274-944-Needle w/ Stealth ER, 44cm, 5mm
Potential for the tip of the electrode to detach during use.
- US
Getinge Usa Sales Inc recalls Getinge CM320 WUWD Series Washer Disinfector-For use as a multi-chamber washer-disinfector for the washing, disinfecting and drying…
Verification of installation not documented or may be incomplete, could result in harm to the user such as skin burns, smoke inhalation, electric shock, or a crush or pinch injury or slip and fall injury. May lead to a…
FDA · DeviceGetinge Usa Sales IncUS Nationwide distribution in the states of MD, MN, ND, NE, NY, PA, VA.Official notice → - US
Siemens Medical Solutions USA, Inc recalls Artis icono biplane -angiography systems developed for single and biplane diagnostic imaging and interventional procedures…
if the protective earth is interrupted and an additional fault leads to a fault current, the detection of the fault current may not be ensured may cause an electric shock if a person is in contact with metallic parts…
- US
Helena Laboratories, Corp. recalls V8 Immunodisplacement Kit REF 1803
Due to microbial growth causing interference with interpretation.
FDA · DeviceHelena Laboratories, Corp.U.S.: FL, MO, OH, and TX O.U.S.: Canada, Uruguay, and Vietnam,Official notice → - US
Siemens Medical Solutions USA, Inc recalls Sensis, Programmable Diagnostic Computer, Model Nos. 6623974 6634633 6634658 6648153 6648161 10140973 10764561 10765502…
Siemens has become aware of three potential software issues with AXIOM Sensis or Sensis/ Sensis Lite systems. This may lead to a hazardous situation for patients if treatment cannot be continued on the system and…