Stryker Recalls MEDPOR BARRIER Sheets for Potential Deformation and Cracking
Stryker is recalling MEDPOR BARRIER Sheets due to risks of deformation, cracking, and loss of adhesion 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) in a medical implant, which aligns with the rubric criteria for 'Severe' severity.
Plain-English summary
Stryker Craniomaxillofacial Division is recalling MEDPOR BARRIER Sheets, which are used for non-weight-bearing craniofacial reconstruction and repair. The recall involves 1,051 units distributed worldwide, including in the United States and various international markets.
The recall was initiated because the implants may deform, have insufficient mechanical stability, lose barrier adhesion, or crack and break during intra-operative use. These defects pose a risk of implant damage and failure during surgical procedures.
Healthcare providers and patients who have received these specific implants should contact Stryker for further instructions on the recall and potential replacement or removal of the devices.
The recalled product
- Product
- MEDPOR BARRIER Sheets Orbital Floor Implant 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…
- 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 (10)
- Part Number 9305
- Lot Numbers 69698
- 77004
- 81799
- A1310051
- A1311008
- A1311044
- A1312011
- A1402023
- A1404010
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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