The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1673-2016·Announced 2016-05-25

Zimmer 3.5 mm Cortical Screws Recalled for Potential Sterility Compromise

Zimmer Manufacturing B.V. is recalling specific lots of 3.5 mm Cortical Screws because a small hole may be present in the inner tray, potentially compromising sterility.

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 sterility compromise in a medical device, which poses a risk of harm (infection) even though no specific injuries or illnesses are reported in the source text.

Plain-English summary

Zimmer Manufacturing B.V. is recalling specific lots of Zimmer Plates and Screws (ZPS) 3.5 mm Cortical Screw SelfTapping. The affected products include screws of various lengths (10 mm, 14 mm, 16 mm, 24 mm, 30 mm, 40 mm, and 75 mm) with specific catalog numbers. The recall involves 794 units distributed worldwide, including the United States, Korea, Japan, and numerous other countries.

The recall is being conducted 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 barrier of the implant. The affected lot numbers are 63252354, 63283819, 63308551, 63252355, 63312340, 63252350, 63283820, and 63243831.

Healthcare providers and facilities should check their inventory for these specific lot numbers and stop using the affected devices. Patients who have received these implants should contact their healthcare provider for guidance.

The recalled product

Product
Zimmer Plates and Screws (ZPS) 3.5 mm Cortical Screw SelfTapping, 10 mm Length 47483501001 3.5 mm Cortical Screw SelfTapping, 14 mm Length 47483501401 3.5 mm Cortical Screw SelfTapping, 16 mm Length 47483501601 3.5 mm Cortical Screw SelfTapping, 24 mm Length 47483502401…
Manufacturer
Zimmer Manufacturing B.V.
Category
Medical Device — Orthopedic Implants
Hazard
Affected units
794

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 →

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