Agency classClass IIOur severity:High FDA (Devices)·Z-1677-2016·Announced 2016-05-25

Zimmer Manufacturing Recalls Sterile Hip and Trauma Implant Screws

Zimmer Manufacturing B.V. is recalling specific lots of sterile Hip and Trauma Implant Screws because a small hole may be present in the inner tray.

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 potential defect in the sterile packaging of an implanted medical device. While no specific injuries or illnesses are reported in the source text, the risk of harm from a compromised sterile implant is significant, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Zimmer Manufacturing B.V. is recalling specific lots of sterile Hip and Trauma Implant Screws. The recall involves 3,955 units of Zimmer Plates and Screws (ZPS), including various 4.0 mm, 4.5 mm, and 6.5 mm cancellous and cortical screws.

The recall is being issued because a small hole may be present in the inner tray of the affected sterile packaging. The source text does not specify the exact nature of the risk associated with the hole, such as whether it compromises sterility or leads to device failure.

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 official recall notice and stop using the affected devices.

The recalled product

Product: Zimmer Plates and Screws (ZPS) 4.0 mm Cancellous Screw Fully Threaded, 12 mm Length 47484001200 4.0 mm Cancellous Screw Fully Threaded, 14 mm Length 47484001400 4.0 mm Cancellous Screw Fully Threaded, 16 mm Length 47484001600 4.0 mm Cancellous Screw Fully Threaded, 18 mm…
Manufacturer: Zimmer Manufacturing B.V.
Category: Medical Device — Orthopedic Implants
Hazard: packaging-defect
sterility-compromise
Affected units: 3,955

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