Stryker Recalls Metaizeau Intramedullary Pins Due to Packaging Seal Concerns
Stryker is recalling 147,838 Metaizeau Intramedullary Pins because packaging seal integrity may be decreased, potentially 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 (sterile medical device) where injury has not yet been reported, fitting the High severity criteria for potential harm without confirmed illness.
Plain-English summary
Stryker Howmedica Osteonics Corp. is recalling 147,838 units of the METAIZEAU Intramedullary Pin, 2.0 x 400 mm (Catalog number 0190-2000S). The device is intended for the temporary stabilization of bone segments or fragments. The recall covers all lots distributed before November 10, 2015, that have a non-expired 5-year shelf life.
The recall was initiated after a review of the packaging determined that the seal integrity of the pouch may be decreased. This defect could potentially compromise the sterility of the medical device. The affected products were distributed nationwide in the United States.
Healthcare providers and facilities should stop using the affected pins and contact Stryker for further instructions on how to return or dispose of the product. Patients who have already received the device should consult their healthcare provider if they have concerns regarding the packaging integrity.
The recalled product
- Product
- Stryker, METAIZEAU Intramedullary Pin, 2.0 x 400 mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.
- Manufacturer
- Stryker Howmedica Osteonics Corp.
- Affected units
- 147,838
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Catalog number 0190-2000S
- All lots distributed before 10 Nov 2015 with non-expired 5 year shelf life
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 18 recalled by Stryker Howmedica Osteonics Corp. 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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