The Recall Desk
Agency classClass IIOur severity:SevereFDA (Devices)·Z-1090-2015·Announced 2015-02-18

Stryker Recalls MEDPOR Surgical Implants Due to Potential Intraoperative Damage

Stryker is recalling MEDPOR Surgical Implants because they may crack or break during surgery. The recall affects 1,051 units distributed worldwide.

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. The hazard involves a structural defect (implant cracking/breaking) during a surgical procedure, which poses a significant risk of injury to the patient, meeting the criteria for a Severe rating.

Plain-English summary

Stryker Craniomaxillofacial Division is recalling MEDPOR Surgical Implant Contoured Two Piece Chin 5 mm units (Part Number 86001; Lot Numbers A1405048, A1404026). The recall involves 1,051 units that were distributed worldwide, including in the United States and various international markets.

The recall was initiated due to a potential for implant damage, specifically the risk of the implant cracking off or breaking intra-operatively. These implants are intended for non-weight-bearing applications of craniofacial reconstruction, cosmetic surgery, and repair of craniofacial trauma.

Healthcare providers and patients who have received these specific implants should contact Stryker for further instructions regarding the recall and potential replacement or removal.

The recalled product

Product
MEDPOR Surgical Implant Contoured Two Piece Chin 5 mm; Part Number 86001; Lot Numbers A1405048, A1404026 Product Usage: MEDPOR Implants in block, sheet and pre-formed shapes are intended for non-weight-bearing applications of craniofacial reconstruction/cosmetic surgery and…
Manufacturer
Stryker Craniomaxillofacial Division
Category
Medical Device — Surgical Implants
Hazard
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 (3)

  • Part Number 86001
  • Lot Numbers A1405048
  • A1404026

Distribution

Distributed nationwide across the United States.

The notice also names 33 states specifically:

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 →

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