Zimmer, Inc. recalls G7 Acetabular System, Acetabular Shell, Item numbers Item Numbers: 010000663 (52 MM E), 010000667 (60 MM G). used in hip arthroplasty
The outer sterile package cavity has a corner wall thickness that is below the specification. The thin corner wall could potentially crack during transit. Potential risks include non-clinically or clinically…
Read the official notice →- Date
- 2022-10-12
- Country
- United States
- Brand
- Zimmer
- Product
- G7 Acetabular System, Acetabular Shell, Item numbers Item Numbers: 010000663 (52 MM E), 010000667 (60 MM G). used in hip arthroplasty
- Classification
- Class II
- Units
- Domestic distribution US nationwide.
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2023-09-13
USZimmer, 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.
FDA · DeviceZimmer, Inc.Worldwide - US Nationwide distribution in the states of AL, CA, GA, MI, NJ,…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…
- 2023-02-15
- US
Zimmer, Inc. recalls Identity Shoulder System Resection Planer 35mm Resection Planer
Two planers were found to be unusable during sawbones shoulder training.
FDA · DeviceZimmer, Inc.US Nationwide distribution in the states of AR, CA, IL, MI, NJ, NY, OK, PA,…Official notice → - 2022-12-21
- US
Zimmer, Inc. recalls NexGen Option Stemmed Tibial Component Size 7, Item Number 00-5986-057-01
Zimmer Biomet is conducting a voluntary medical device recall related to the NexGen Stemmed Option Tibial Components due to the clinically and statistically significant higher overall revision rates when these tibial…
Other drugs & medical recalls in the United States
- 2022-10-12
- US
Philips Respironics, Inc. recalls Wisp and Wisp Youth Nasal Mask
No contraindication/warning regarding magnetic components in CPAP masks for patients with implantable devices or metallic splinters in the eyes.
FDA · DevicePhilips Respironics, Inc.Worldwide distribution - US Nationwide distribution including in the states of…Official notice → - US
B Braun Medical Inc recalls Introcan Safety FEP 14G, 2.2x32MM-US, Product Code 4251890-02. A passive anti-needle device to provide venous or arterial access.
Potential for leakage at the catheter hub.
FDA · DeviceB Braun Medical IncDomestic distribution to AZ CA FL GA MD MI MO MS NC NY OH PA TN TX WA. Foreign…Official notice → - US
Synthes (USA) Products LLC recalls Hammertoe Continuous Compression Implant (CCI) Kit Part Number: 46.239.001
Drill Pin (drill bit) is not compatible with the Drill Template included in the kit due to a packaging error, result in a surgical delay and may cause soft tissue damage if a larger incision is required to accommodate…
- US
Wright Medical Technology, Inc. recalls stryker EVOLVE, Proline Stem, CoCr, Size: +4, OD: 9.5mm, REF 496S275, Wright s EVOLVE Proline Plus Radial Head and Repair System…
The outer label does not match the device inside the package. The affected lot of EVOLVE Proline Stem 7.5mm +2 contains a size 9.5mm +4 stem, while the affected lot of EVOLVE Proline Stem 9.5mm +4 contains a size 7.5mm…
- US
Philips North America Llc recalls MR Patient Care Portal 5000 (Desktop Unit), Model Number 453564792561 This is a component of product number 866162.
Device may intermittently fail to produce audio. Turning the unit off and on does not resolve the issue; disconnecting and reconnecting to AC power does not reliably resolve the issue.
FDA · DevicePhilips North America LlcDomestic distribution to AL AZ CA CO FL GA ID IL IN LA MA MI MN NC NE NJ OH PA…Official notice → - US