Zimmer Versa-FX II Keyless Bone Fixation Devices Recalled for Sterility Concerns
Zimmer Manufacturing B.V. is recalling 5,538 units of Versa-FX II Keyless bone fixation devices 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 the hazard is theoretical (potential loss of sterility) and no injuries or illnesses have been reported.
Plain-English summary
Zimmer Manufacturing B.V. is recalling 5,538 units of Versa-FX II Keyless bone fixation devices, including various short, tube, and plate components. These single or multiple component metallic bone fixation appliances are intended to be implanted to fix fractures of long bones or for joint fusion.
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 calibration issue raises concerns regarding the integrity of the sterile packaging.
The affected products were distributed nationwide in the United States. Healthcare providers and patients should contact Zimmer Manufacturing B.V. for further instructions on the recall and potential replacement or refund options.
The recalled product
- Product
- Product 65 consists of all product under product code: KTT and same usage: Item no: 119413594 VERSA-FX II KEYLESS SHORT 119413595 VERSA-FX II KEYLESS SHORT 119413596 VERSA-FX II KEYLESS SHORT 119413004 VERSA-FX II KEYLESS TUBE 119413005 VERSA-FX II KEYLESS TUBE 119413006…
- Manufacturer
- Zimmer Manufacturing B.V.
- Hazard
- Affected units
- 5,538
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 →Related recalls
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Similar recalls
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