HighFDA (Devices)·Z-1700-2025·Announced 2025-05-07

[pending] Posterior Femoral Augment; Item Numbers: (1) 880-310/11 (Sz. 0 - cemented sm), (2) 880-310/21 (Sz. 0

Pending LLM rewrite. Source: FDA_DEVICE Z-1700-2025.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Pending LLM scoring against the rubric.

The device was delivered with a preassembled Femoral Augment screw that was missing its thread.

Product: Posterior Femoral Augment; Item Numbers: (1) 880-310/11 (Sz. 0 - cemented sm), (2) 880-310/21 (Sz. 0 - cemented lg), (3) 880-311/11 (Sz. 1-2 - cemented sm), (4) 880-311/21 (Sz. 1-2 - cemented lg), (5) 880-313/11 (Sz. 3-4 - cemented sm), (6) 880-313/12 (Sz. 3-4 - cemented md), (7)
Manufacturer: Waldemar Link GmbH & Co. KG (Mfg Site)
Category: Medical Device — Devices

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

Item Number/UDI-DI: (1) 880-310/11 (04026575257539)
(2) 880-310/21 (04026575257546)
(3) 880-311/11 (04026575257607)
(4) 880-311/21 (04026575257584)
(5) 880-313/11 (04026575257621)
(6) 880-313/12 (04026575257645)
(7) 880-313/21 (04026575257669)
(8) 880-313/22 (04026575257690)
(9) 880-315/11 (04026575257768)
(10) 880-315/12 (04026575257775)
(11) 880-315/21 (04026575257782)
(12) 880-315/22 (04026575257799)
(13) 880-317/11 (04026575257843)
(14) 880-317/12 (04026575257850)
(15) 880-317/21 (04026575257867)
(16) 880-317/22 (04026575257881)
(17) 880-319/11 (04026575257942)
(18) 880-319/12 (04026575257959)
(19) 880-319/21 (04026575257966)
manufactured up until 03/01/2025.

Distributed nationwide across the United States.

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