Recall Z-1090-2015— Stryker Craniomaxillofacial Division
Class II · Terminated
Class II FDA medical device recall by Stryker Craniomaxillofacial Division, initiated 2014-12-17, terminated 2015-11-06. It names one FDA 510(k) clearance: K922489. 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 repair of craniofacial trauma. MEDPOR Surgical Implants and MEDPOR BARRIER Implants are intended for the augmentation or restoration of bony contour in the craniofacial skeleton.. Reason: Potential for implant damage, implant cracking off/breaking intra-operatively..
- Recalling firm
- Stryker Craniomaxillofacial Division
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-12-17
- Terminated
- 2015-11-06
- Firm location
- Portage, MI, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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 repair of craniofacial trauma. MEDPOR Surgical Implants and MEDPOR BARRIER Implants are intended for the augmentation or restoration of bony contour in the craniofacial skeleton.
Reason for recall
Potential for implant damage, implant cracking off/breaking intra-operatively.
Data sourced from openFDA. This site is unofficial and independent of the FDA.