Zimmer GmbH Recalls CBS Micro Countersink Cannulated Round-Shaft Screws
Zimmer GmbH is recalling CBS micro countersink cannulated round-shaft screws because they may be made from the wrong material.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a potential material defect that could compromise safety, but no specific injuries or illnesses are reported in the source text, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Zimmer GmbH is recalling CBS micro, countersink, cannulated, round-shaft screws, Item Number 503004341. The recall was initiated after an investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
The affected products are distributed to hospitals and medical facilities in 39 US states, including Alabama, Arizona, California, Florida, Georgia, Illinois, New York, and Texas. All items marked with "Normed" are affected by this recall.
Healthcare providers should stop using the affected devices and contact Zimmer GmbH for further instructions on the recall process.
The recalled product
- Product
- CBS micro, countersink, cannulated, round-shaft, Item Number 503004341
- Manufacturer
- Zimmer GmbH
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All items marked with "Normed" are affected
Distribution
Part of a larger recall action
This product is one of 76 recalled by Zimmer GmbH under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 76 products in this recall →Related recalls
Same manufacturer · Zimmer GmbH
See all →- HighBiolox Taper Sleeve Mislabeling: Wrong Component Size in Hip Replacement
FDA (Devices) · 2024-09-18
- ModerateZimmer GmbH Recalls Mislabeled Biolox Option Taper Sleeve for Hip Replacement
FDA (Devices) · 2024-09-18
- HighZimmer Femoral Nail Recall: Risk of Commingled Angle Versions
FDA (Devices) · 2021-06-09
- HighZimmer Natural Nail cephalomedullary device angle mismatch recall
FDA (Devices) · 2021-06-09
- ModerateZimmer Sidus Stem-Free Shoulder Humeral Head Recall for Incorrect Labeling
FDA (Devices) · 2019-10-09
Same hazard · material defect
See all →- HighICU Medical Recalls Plum Administration Sets Due to Drip Chamber Discoloration
FDA (Devices) · 2026-09-23
- HighICU Medical Recalls IV Sets with Potential Drip Chamber Discoloration
FDA (Devices) · 2026-09-23
- ModerateParagon 28 Recalls Custom Foot Implant Due to Material Defect
FDA (Devices) · 2026-08-26
- LowParagon 28 Recalls Custom Foot Implant Due to Material Defect
FDA (Devices) · 2026-08-26
- HighNexxZr dental zirconia discs may have reduced or missing dentin layer
FDA (Devices) · 2026-06-17
Similar recalls
- HighZimmer Werber Countersink Instruments Recalled Due to Material Defect
FDA (Devices) · 2017-05-24
- HighZimmer Recalls Magna-Fx Cannulated Bone Screws Due to Leak Test Failure
FDA (Devices) · 2014-08-27
- ModerateZimmer Recalls Magna-Fx Cannulated Bone Screws Due to Leak Test Failures
FDA (Devices) · 2014-08-27
- ModerateZimmer Manufacturing Recalls Compression Screws Due to Sealer Calibration Issues
FDA (Devices) · 2016-03-23
- HighZimmer Biomet Recalls Herbert Cannulated Bone Screw System Drills
FDA (Devices) · 2017-10-04
- ModerateZimmer Recalls Magna-Fx Cannulated Screws Due to Packaging Validation Issues
FDA (Devices) · 2014-02-26