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…
Read the official notice →- Date
- 2023-04-05
- Country
- United States
- Brand
- Zimmer
- Product
- 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…
- Classification
- Class II
- Units
- AL AZ CO FL LA MI OH OK TX Foreign: Canada
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
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- Check the product name, strength and lot number against the official notice.
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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.
- 2023-02-15
- 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…
- 2022-10-12
- US
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…
Other drugs & medical recalls in the United States
- 2023-04-05
- US
Instrumentation Laboratory recalls ACL ELITE Refurbished-Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or…
Removes the test definition for HemosIL Liquid Anti-Xa (PN 0020302600 and 0020302601) from the ACL Elite/Elite Pro instruments
FDA · DeviceInstrumentation LaboratoryWorldwide distribution - US Nationwide and the countries of Canada, Albania,…Official notice → - US
Atrium Medical Corporation recalls Express Mini 500 Dry Seal Chest Drain, Part Number 16400
The Instructions for Use (IFU) for the Pneumostat Chest Drain Valve and the Express Mini 500 Dry Seal Chest Drains do not provide sufficient precaution against draining the device for continued use. Additionally, the…
FDA · DeviceAtrium Medical CorporationWorldwide distribution - US Nationwide and the countries of United Arab…Official notice → - US
Entopsis , Inc. recalls PCRopsis Lysis Beads, IVDD: a) 25 tubes , REF 597000; b) 25 tubes, REF 597825; c) 50 tubes, REF 597850; d) 25 grams, REF 5970025; e) 1000…
Presence of misleading label statements on the product label.
FDA · DeviceEntopsis , Inc.Nationwide and Canada, UK, Portugal, England, Spain, England , Germany,…Official notice → - US
Intuitive Surgical, Inc. recalls da Vinci Xi Surgical System Model IS4000 da Vinci X Surgical System Model IS4200
Due to Universal Surgical Manipulator (USM) instrument carriage being loose as a result of the linear rail component not being manufactured within specifications.
FDA · DeviceIntuitive Surgical, Inc.U.S.: Cayman Islands, Dominican Republic, Puerto Rico, United States O.U.S.:…Official notice → - US
Brainlab AG recalls Cirq Arm System 2.0
Risk of mechanical instability due to potential manufacturing error of the device
- US
Alcon Research, LLC recalls Alcon Custom Pak Surgical Procedure Pack: Pak Number & Pak Description: 17533-04 DR GROSS LPS LLC 18704-03 CATARACT SURGI CARE 18382-03 DR…
Sterility; Steril surgical procedure packs contain incomplete seals.
FDA · DeviceAlcon Research, LLCUS: AL, AR, CA, IA, ID, IN, KY, MN, NC, ND, NJ, OH, PA, TX, OUS: NoneOfficial notice →