Z-1921-2018 Class II Terminated
FDA device recall Z-1921-2018 was initiated by Smith & Nephew, Inc. on May 2, 2018 and is designated Class II. Reason for recall: Three lots of Anthology HO Porous size 7 stems were manufactured with an undersized taper length. The device taper length was incorrectly manufactured as 0.393mm opposed to 0.442 mm. The recall status is terminated (terminated Sep 1, 2020). Affected quantity: 13 units.
Recall Details
- Product Type
- Devices
- Report Date
- May 30, 2018
- Initiation Date
- May 2, 2018
- Termination Date
- Sep 1, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 13 units
Product Description
smith&nephew ANTHOLOGY POROUS HIGH OFFSET STEM, 12/14 TAPER, 7H SIZE, 32 MM x 112 MM, REF 71356107 Hip prosthesis.
Reason for Recall
Three lots of Anthology HO Porous size 7 stems were manufactured with an undersized taper length. The device taper length was incorrectly manufactured as 0.393mm opposed to 0.442 mm.
Distribution Pattern
US nationwide distribution.
Code Information
Lot Numbers: 17LM22019, 17LM10934, 17LM05900
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1921-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026