Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1139-2016·Announced 2016-03-23

Zimmer Manufacturing Recalls Sterile Bone Fixation Screws Due to Calibration Issues

Zimmer Manufacturing B.V. is recalling specific sterile bone fixation screws due to insufficient sealer calibration data for products packaged between August 2010 and April 2013.

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. The hazard involves insufficient sealer calibration data, which is a packaging integrity issue. No illnesses or injuries are reported in the source text, and the risk is theoretical regarding sterility maintenance, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Zimmer Manufacturing B.V. is recalling specific sterile bone fixation screws, identified as Product 41 under product code KTT. The recall involves 6,059 units of various lengths and diameters, including 12.7D and 15.8D screws, which are intended for the fixation of fractures in long bones.

The recall was initiated because of insufficient sealer calibration data for products packaged in the firm's Building II between August 2010 and April 2013. The affected products are sterile, and the issue relates to the packaging process rather than the metallic components themselves.

The affected products were distributed nationwide in the United States. Healthcare providers and facilities should check their inventory for the specific lot numbers listed in the recall notice and stop using any affected units. Patients who have already had these devices implanted should contact their healthcare provider for guidance.

The recalled product

Product: Product 41 consists of all product under product code: KTT and same usage: Item no: 119301042 LAG SCR 12.7D X 100MM STA 119301045 LAG SCR 12.7D X 105MM STA 119301047 LAG SCR 12.7D X 110MM STA 119301050 LAG SCR 12.7D X 115MM STA 119301052 LAG SCR 12.7D X 120MM STA…
Manufacturer: Zimmer Manufacturing B.V.
Category: Medical Device — Orthopedic Implants
Hazard: sterility-compromise
packaging-defect
Affected units: 6,059

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 72 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 72 products in this recall →

Same manufacturer · Zimmer Manufacturing B.V.

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Same hazard · sterility compromise