Stryker Locking Screw Recall Due to Potential Sterility Compromise
Stryker is recalling specific lots of Locking Screws because the blister pack seal may be compromised, meaning sterility cannot be assured.
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 implant) where the hazard is theoretical (potential sterility compromise) and no injuries or illnesses have been reported in the source text.
Plain-English summary
Stryker GmbH is recalling specific lots of Stryker Locking Screws, Fully Threaded T2 Tibia 5x35 mm (Catalog Number: 18965035S). These single-use medical devices are intended for the temporary fixation, correction, or stabilization of bones.
The recall is being conducted because the seal integrity of the blister pack may be compromised, which means the sterility of the devices cannot be assured. The affected lots are distributed worldwide, including in the United States and numerous international markets.
Healthcare providers and facilities should stop using the affected lots and contact Stryker for instructions on how to return or dispose of the devices. Patients who have already received these implants should consult their healthcare provider if they have concerns regarding the sterility of the device.
The recalled product
- Product
- Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x35 mm Catalog Number: 18965035S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.
- Manufacturer
- Stryker GmbH
- Affected units
- 1,404
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 (20)
- Lot Number: K02AE3F
- K02C191
- K02C1AA
- K0302F9
- K0302FA
- K0302FD
- K030307
- K030313
- K030315
- K030EE3
- K030EE4
- K030EE5
- K030EE8
- K031B63
- K032879
- K0E902D
- K0E9086
- K0E90B7
- K0E90BB
- K0EAC03
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 15 recalled by Stryker GmbH 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 15 products in this recall →Related recalls
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