Zimmer, Inc. recalls M/L Taper Hip Prosthesis Extended Offset, Reduced Neck Length, Size 4 (Item Number 00771100640) and Size 6 (Item Number 00771100440)
The outer package labeling and product etch are for a Size 6, however, the implant is a Size 4, and vice versa.
Read the official notice →- Date
- 2023-09-13
- Country
- United States
- Brand
- Zimmer
- Product
- M/L Taper Hip Prosthesis Extended Offset, Reduced Neck Length, Size 4 (Item Number 00771100640) and Size 6 (Item Number 00771100440)
- Classification
- Class II
- Units
- Worldwide - US Nationwide distribution in the states of AL, CA, GA, MI, NJ,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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 Zimmer recalls
- 2024-08-07
US
Zimmer, Inc. recalls CPT Hip Joint Metal/Polymer Semi-Constrained Cemented Prosthesis, used in Hip Arthroplasty; Item Numbers 00811400000 00811400010…
Affected product has an increased risk of postoperative perisprosthetic femoral fracture (PFF). The IFU is being updated to reflect the risk of PFF.
- 2024-05-08
US
Zimmer, Inc. recalls ZPLP(Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Left, 6 Holes, 106 MM, Sterile- Indicated for temporary…
Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user since the screw may not correctly lock,…
FDA · DeviceZimmer, Inc.Worldwide distribution - US Nationwide and the countries of Brazil, Canada,…Official notice →- 2024-05-01
US
Zimmer, Inc. recalls NexGen CR-Flex Femoral Component, Size E and Size E Minus (E-). Component of the NexGen CR-Flex Porous Femur System.
Out of specification violation of devices that results in a gap existing within the fixture that presses the fiber metal pad to the substrate, causing the pad to not fully bond to the substrate.
FDA · DeviceZimmer, Inc.Worldwide distribution - US Nationwide including the states of AK, AL, CA, FL,…Official notice →- 2023-08-09
US
Zimmer, Inc. recalls Zimmer Periarticular Locking Plate (ZPLP) Distal Lateral Femoral Plate 6 holes 159 mm Length-Indicated for temporary internal fixation and…
Thread form issue of the locking holes in that the locking screws would not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user since the screw may not correctly lock.
FDA · DeviceZimmer, Inc.AR AZ MA ME MO NJ NM NY OR WA Foreign: Brazil China Dominican Republic Korea…Official notice →- 2023-07-12
US
Zimmer, Inc. recalls NexGen Precoat Stemmed Tibial Plate Size 5
Device outer packaging was incorrectly labeled.
- 2023-04-05
US
Zimmer, Inc. recalls CoCr Femoral Head, XS, 38/-8, Taper 12/14-Intended to be used as a modular head component for articulation in total hip arthroplasty. Item…
Update the compatibility matrix as referred to in the Instructions for Use (IFU) for the CoCr Femoral Head XS- removes the compatibility with the Epsilon Durasul Constrained Acetabular Liners from the matrix due to the…
Other drugs & medical recalls in the United States
- 2023-09-20
US
BE PHARMACEUTICALS AG recalls Pantoprazole Sodium for Injection 40mg per vial, Single dose vials NDC 71839-122-01 Packaged as (a) 10 Single-dose vials, NDC…
Lack of Assurance of Sterility: Powder discoloration due to small crack in some vials.
- 2023-09-13
US
Aomori Olympus Co., Ltd. recalls Olympus Distal Attachment (in Olympus Disposable EMR Kit)- Designed to be attached to the distal end of the endoscope. Disposable EMR…
The Distal Attachment contain di-2-ethylhexyl phthalate (DEHP), which exceeds the permissible exposure level calculated according to ISO 10993-17: 2002
US
Diversatek Healthcare recalls ZVU Functional GI Software, REF: ZVU-3
GI Software labelled as revision 3.3.0 is incorrectly labeled and is in fact revision 3.2.0.
FDA · DeviceDiversatek Healthcareworldwide - US Nationwide distribution in the states of NJ, MN, TN, WA, KY,…Official notice →US
Aesculap Implant Systems LLC recalls For intraventricular indications mainly used for operations within the brain ventricles. Product Code: FF399R
Trocar manufactured with the shaft too long and does not meet manufacturing specifications. As a result, when used with the 30¿ neuroendoscope, a portion of the visual field is obscured.
FDA · DeviceAesculap Implant Systems LLCUS Nationwide distribution in the states of FL, ID, IL, MD, NC, NY, OR, RI, TX.Official notice →US
Philips Ultrasound, Inc. recalls 3D9-3v Transducer, accessory to Philips Ultrasound Systems: EPIQ Elite; Affiniti 30, 50, and 70; ClearVue 850; HD15; iU22; and Compact…
Transducer, an ultrasound system accessory, consists of two parts that are bonded together that may come apart due to chassis bonding issue, which may pose risk to users and patients of tissue damage, and electric…
FDA · DevicePhilips Ultrasound, Inc.Worldwide - US Nationwide distribution including in the states of FL, MN, AZ,…Official notice →US
PARAGON VISION SCIENCES, Inc recalls ISee Ortho-K Lens
Manufactured lenses are not covered by existing FDA approval
FDA · DevicePARAGON VISION SCIENCES, IncWorldwide distribution - US Nationwide distribution including in the states of…Official notice →