Zimmer, Inc. recalls Saphena Medical Venapax XL- Endoscopic Vessel Harvesting System for use in minimally invasive surgery allowing access for vessel…
A Gen 5 tail piece was assembled to a Gen 4 Finished Device, resulting in a 0.178" difference in the end of the endoscope slot to the end of the tail piece. This allows the scope to move further into the plastic sheath…
Read the official notice →- Date
- 2024-11-13
- Country
- United States
- Brand
- Zimmer
- Product
- Saphena Medical Venapax XL- Endoscopic Vessel Harvesting System for use in minimally invasive surgery allowing access for vessel…
- Classification
- Class II
- Units
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2025-04-02
US
Zimmer, Inc. recalls NexGen LPS Flex, Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis, Model Number 00-5962-042-10
The "Use with plate 7, 8, 9, 10" compatibility statement on top of the label does not match with the compatibility statements "USE WITH PLATE 5, 6" in the translations section of the same label.
FDA · DeviceZimmer, Inc.Worldwide - US Nationwide distribution in the states pf CA, KS, MA, MD, ME,…Official notice →- 2025-03-19
US
Zimmer, Inc. recalls Z1 Femoral Hip System, Product Number 611777612
There is a potential design issue with the Z1 Offset Stem Inserter leading to fracturing of the distal tip.
- 2025-02-05
US
Zimmer, Inc. recalls NexGen LCCK Legacy Articular Surface with Locking Screw - Striped Yellow/E,F - Height 10 mm, Item Number 00-5994-032-10
It was identified internally that two commingle events occurred where the metal support post within the polyethylene articular surface was assembled incorrectly for three units within the scope.
FDA · DeviceZimmer, Inc.Worldwide - US Nationwide distribution in the states of CA, FL, GA, KS, MO,…Official notice →- 2024-09-18
US
Zimmer GmbH recalls Biolox Option Taper Sleeve, Type 1 Taper, -6mm Neck - Indicated for use in total hip replacement with cemented or non-cemented femoral and…
Mislabeled: Incorrect sleeve in the packaging. The outer packaging is labeled as a standard neck sleeve, however, the product within the box is a -6mm neck sleeve, and vice versa. The neck of the sleeve can be…
FDA · DeviceZimmer GmbHWorldwide distribution - US Nationwide and the countries of Japan, Netherlands.Official notice →- 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 →
Other drugs & medical recalls in the United States
- 2024-11-13
US
Iotamotion Inc recalls iotaSOFT Plus Drive Unit, REF IM-05. The iotaSOFT Insertion System is intended to aid the surgeon in placement of cochlear implant…
Incorrect GTIN number.
FDA · DeviceIotamotion IncDistribution was made to Iowa. There was no government/military/foreign…Official notice →US
American Surgical Company, LLC recalls Americot 20-01S (1/4" x 1/4") or 6mm x 6mm: Neurological sponges for use in the protection of neural tissue during surgery. Ref:…
Product defect where the X-ray detectable barium strip (aka radio-opaque marker) becomes detached from the sponge (pattie). May delay surgical process as the surgeon may require extra time to remove the markers from…
FDA · DeviceAmerican Surgical Company, LLCCA, IA, IL, MN, MO, NY, OH, VA Foreign: Australia, Belgium, Hungry, Italy,…Official notice →US
Siemens Healthcare Diagnostics Inc recalls epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System, SMN 10736515
Siemens Healthcare Diagnostics Inc. has confirmed that a negative sodium bias may exist in one lot of epoc BGEM BUN Test Cards approximately 2 months prior to expiration. The observed maximum negative bias from…
US
Canon Medical System, USA, INC. recalls Cartesion Prime, Digital PET-CT, Model: PCD-1000A/3D.004, PCD-1000A/3D, is a diagnostic imaging system that combines Positron…
When PET-CT system is executing reconstruction, if PET acquisition for another patient is performed (or PET reconstruction for another patient is performed from raw data processing), PET reconstruction control…
FDA · DeviceCanon Medical System, USA, INC.US: NV, AR, MN, IA, IL, NC, LA, KS, MS, CA, AL, MD, CO, IN, TN, AZ, WI, VAOfficial notice →US
Elekta Instrument AB recalls Elekta Disposable Biopsy Needle Kit for Leksell Stereotactic System, REF 911933, Diameter / 14 Gauge, containing 6 inner boxes labeled REF…
Elekta has become aware that Disposable Biopsy Needles can contain some microscopic debris on the inside of the biopsy needle. The material in the debris is stainless steel, same material as the biopsy needle. No…
US
Direct Rx recalls Ibuprofen 800mg, Generic for: Motrin, Each tablet contains: Ibuprofen, USP 800 mg, Packaged and Distributed by: DIRECT Rx, Dawsonville, GA…
Failed Impurities/Degradation Specifications: Product failed impurity specifications at the 18-month stability testing.