Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1679-2016·Announced 2016-05-25

Zimmer Manufacturing Recalls Mini MagnaFx Cannulated Bone Screws

Zimmer Manufacturing B.V. is recalling specific lots of Mini MagnaFx and MagnaFx cannulated bone screws due to a potential small hole in the inner tray of the sterile packaging.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, which is generally associated with a temporary or medically reversible adverse health consequence. The hazard is a packaging defect (hole in the tray) that may compromise sterility, but no specific injuries or illnesses are reported in the source text, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

Zimmer Manufacturing B.V. is recalling 751 units of Mini MagnaFx and MagnaFx Cannulated Screw Fixation System bone screws. The recall involves specific lots of sterile Hip and Trauma Implant Screws, including various diameters and lengths of fully and partially threaded screws.

The recall was initiated because a small hole may be present in the inner tray of the sterile packaging for these specific lots. This defect could potentially compromise the sterile integrity of the medical devices.

The affected products were distributed worldwide, including in the United States, Korea, Japan, Argentina, Brazil, Singapore, Taiwan, China, El Salvador, Australia, India, Hong Kong, Chile, Germany, Italy, France, Spain, the UK, Sweden, and Canada. Healthcare providers and facilities should check their inventory for the specific lot numbers listed in the recall notice and stop using any affected units.

The recalled product

Product: Mini MagnaFx Cannulated Screw Fixation System Small Cannulated Bone Screw, Fully Threaded, 5.0 mm Diameter, 20 mm Length 00114205020 Mini Magna-Fx Cannulated Screw Fixation System Small Cannulated Bone Screw, Fully Threaded, 5.0 mm Diameter, 36 mm Length 00114205036 Mini…
Manufacturer: Zimmer Manufacturing B.V.
Category: Medical Device — Orthopedic Implants
Hazard: packaging-defect
sterility-compromise
Affected units: 751

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 12 recalled by Zimmer Manufacturing B.V. 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 12 products in this recall →

Same manufacturer · Zimmer Manufacturing B.V.

See all →

High
Zimmer 3.5 mm Cortical Screws Recalled for Potential Sterility Compromise
FDA (Devices) · 2016-05-25
High
Zimmer Manufacturing Recalls Sterile Hip and Trauma Implant Screws
FDA (Devices) · 2016-05-25
High
Zimmer VersaFx Femoral Fixation System Screws Recalled for Sterility Concerns
FDA (Devices) · 2016-05-25
High
Zimmer Herbert Cannulated Bone Screw Recall for Sterility Concerns
FDA (Devices) · 2016-05-25
Moderate
Zimmer Recalls Sterile Hip and Trauma Implant Screws Due to Tray Defect
FDA (Devices) · 2016-05-25

Same hazard · packaging defect