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U.S. Department of Health and Human Services

Class 2 Device Recall Aequalis Pyrocarbon Humeral Heads

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  Class 2 Device Recall Aequalis Pyrocarbon Humeral Heads see related information
Date Initiated by Firm June 25, 2021
Create Date August 13, 2021
Recall Status1 Open3, Classified
Recall Number Z-2291-2021
Recall Event ID 88174
Product Classification Shoulder arthroplasty implantation system - Product Code QHE
Product The Aequalis Pyrocarbon Humeral Heads. Shoulder implant component. Sold OUS only:
a) Catalog # DWH039 - Diameter 39 mm Height 14 mm Eccentric LOW (1.5) Material PyC/CoCr,
b) Catalog # DWH041 - Diameter 41 m m Height 15 mm Eccentric LOW (1.5) Material PyC/CoCr,
c) Catalog # DWH043 - Diameter 43 mm Height 16 mm Eccentric LOW (1.5) Material PyC/CoCr,
d) Catalog # DWH046 - Diameter 46 mm Height 17 mm Eccentric LOW (1.5) Material PyC/CoCr,
e) Catalog # DWH048 - Diameter 48 mm Height 18 mm Eccentric LOW (1.5) Material PyC/CoCr,
f) Catalog # DWH050 - Diameter 50 mm Height 16 mm Eccentric LOW (1.5) Material PyC/CoCr,
g) Catalog # DWH051 - Diameter 50 mm Height 19 mm Eccentric LOW (1.5) Material PyC/CoCr,
h) Catalog # DWH052 - Diameter 52 mm Height 19 mm Eccentric LOW (1.5) Material PyC/CoCr,
i) Catalog # - DWH053 - Diameter 52 mm Height 23 mm Eccentric LOW (1.5) Material PyC/CoCr,
j) Catalog # DWH054 - Diameter 54 mm Height 23 mm Eccentric LOW (1.5) Material PyC/CoCr,
k) Catalog # DWH139 - Diameter 39 mm Height 14 mm Eccentric HIGH (3.5) Material PyC/CoCr,
l) Catalog # DWH141 - Diameter 41 mm Height 15 mm Eccentric HIGH (3.5) Material PyC/CoCr,
m) Catalog # DWH143 - Diameter 43 mm Height 16 mm Eccentric HIGH (3.5) Material PyC/CoCr,
n) Catalog # DWH146 - 46 mm Height 17 mm Eccentric HIGH (4) Material PyC/CoCr,
o) Catalog # DWH148, - Diameter 48 mm Height 18 mm Eccentric HIGH (4) Material PyC/CoCr,
p) Catalog # DWH150 - Diameter 50 mm Height 16 mm Eccentric HIGH (4) Material PyC/CoCr,
q) Catalog # DWH151 - Diameter 50 mm Height 19 mm Eccentric HIGH (4) Material PyC/CoCr,
r) Catalog # DWH152 - Diameter 52 mm Height 19 mm Eccentric HIGH (4) Material PyC/CoCr,
s) Catalog # DWH153 - Diameter 52 mm Height 23 mm Eccentric HIGH (4) Material PyC/CoCr,
t) Catalog # DWH154 - Diameter 54 mm Height 23 mm Eccentric HIGH (4) Material PyC/CoCr,
Code Information All Lot Codes
Recalling Firm/
Manufacturer		 Tornier S.A.S.
161 Rue Lavoisier
Montbonnot St Martin France
For Additional Information Contact Ms. Meghan Wells
901-201-9298
Manufacturer Reason
for Recall		 Potential patient exposure to the graphite substrate.
FDA Determined
Cause 2		 Device Design
Action On June 25, 2021 Tornier sent the following notification by letter: With regards to cases where this product has already been implanted, we suggest that physicians check for the potential presence of metallic bodies in the shoulder joint and adapt patient monitoring, as appropriate, when metallic bodies are present. Otherwise, we suggest that physicians continue the monitoring of patients per their standard clinical protocols. Actions needed 1. Please circulate this Field Safety Notice to all surgeons using AEQUALIS" PYROCARBON Humeral Head Implant 2. Maintain awareness of this communication internally until all required actions have been completed within your facility. 3. Return the enclosed business reply form by email to FieldAction@wright.com within 7 days to confirm receipt of this notification. 4. Inform Tornier SAS if any of the subject devices have been distributed to other organizations. If so, provide contact details so Tornier SAS can inform the recipients appropriately. 5. Please inform Tornier SAS of any adverse event and/or report them to the Competent Authorities in accordance with current regulations and in compliance with MEDDEV 2.12 If you have any questions or concerns, please contact Customer Service +1 888 494 7950.
Quantity in Commerce 6631 units
Distribution CA, CO, CT, FL, KS, LA, MD, MI, MN, MO, NC, OR, PA, TX and WI
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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