Recall Z-2291-2021
Tornier S.A.S. · initiated June 25, 2021
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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,
Codes / lots: All Lot Codes
Reason for recall
Potential patient exposure to the graphite substrate.
FDA-determined cause: Device Design
Action taken
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.
Details
- Recall number
- Z-2291-2021
- Initiated
- June 25, 2021
- Product code
- QHE – Shoulder Arthroplasty Implantation System
- Quantity
- 6631 units
- Distribution
- CA, CO, CT, FL, KS, LA, MD, MI, MN, MO, NC, OR, PA, TX and WI
- Recalling firm
- Tornier S.A.S., Montbonnot St Martin