Zimmer Manufacturing Recalls Free-Lock Lag Screws Due to Sterility Concerns
Zimmer Manufacturing B.V. is recalling 3,500 units of Free-Lock Lag Screws and related bone fixation products due to insufficient sealer calibration data affecting 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 risk-of-harm product (implanted medical device) where sterility is compromised, but no injuries or illnesses have been reported, fitting the 'High' severity criteria for theoretical risk without reported harm.
Plain-English summary
Zimmer Manufacturing B.V. is recalling 3,500 units of Free-Lock Lag Screws, Free-Lock Supracond Tubes, and Free-Lock Tube & SCP Plate products. These are single or multiple component metallic bone fixation appliances intended for implantation to fix fractures or fuse joints. The affected products were distributed nationwide in the United States.
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. This issue affects the sterility of the devices. The source text does not report any illnesses or injuries associated with these products.
Healthcare providers and patients should contact Zimmer Manufacturing B.V. for instructions on how to handle the affected devices. The recall covers specific lot numbers listed in the official FDA record Z-1128-2016.
The recalled product
- Product
- Product 30 consists of all product under product code: KTT and same usage: Item no: 118100527 FREE-LOCK LAG SCREW, 12.7 118100535 FREE-LOCK LAG SCREW, 12.7 118100540 FREE-LOCK LAG SCREW, 12.7 118100542 FREE-LOCK LAG SCREW, 12.7 118101022 FREE-LOCK LAG SCREW, 12.7…
- Manufacturer
- Zimmer Manufacturing B.V.
- Affected units
- 3,500
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.
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