Stryker Recalls MEDPOR BARRIER Sheets Due to Deformation and Cracking Risks
Stryker is recalling MEDPOR BARRIER Sheets due to potential implant deformation, mechanical instability, and cracking during surgery.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a structural defect (deformation, cracking, mechanical instability) in a medical implant, which aligns with the rubric criteria for 'Severe' severity involving structural defects or significant injury risks.
Plain-English summary
Stryker Craniomaxillofacial Division is recalling MEDPOR BARRIER Sheets, Rectangle, Part Number 9312, Lot Number A1403008. The recall involves 1,051 units that were distributed worldwide, including nationwide in the United States and in several international countries.
The recall was initiated because of a potential for implant deformation, insufficient mechanical stability, loss of barrier adhesion during surgery, implant damage, and cracking or breaking of the implant intra-operatively. These implants are intended for non-weight-bearing applications in craniofacial reconstruction, cosmetic surgery, and repair of craniofacial trauma.
Healthcare providers and patients who have received these specific implants should contact Stryker Craniomaxillofacial Division for further instructions regarding the recall and potential replacement or removal of the devices.
The recalled product
- Product
- MEDPOR BARRIER Sheets Rectangle Product Usage: MEDPOR Implants in block, sheet and pre-formed shapes are intended for non-weight-bearing applications of craniofacial reconstruction/cosmetic surgery and repair of craniofacial trauma. MEDPOR Surgical Implants and MEDPOR…
- Manufacturer
- Stryker Craniomaxillofacial Division
- Affected units
- 1,051
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)
- Part Number 9312
- Lot Number A1403008
Distribution
Part of a larger recall action
This product is one of 4 recalled by Stryker Craniomaxillofacial Division 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 4 products in this recall →Related recalls
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