Corin Ltd Unit 1-57-8 Corinium Centre Cirencester United Kingdom TaperFit Stem, Size 0, 38mm OFFSET, 12/14 Taper + 188.550 Centraliser, For Cemented Use, REF 588.3800. Orthopedic hip implant component. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
TaperFit Stem, Size 0, 38mm OFFSET, 12/14 Taper + 188.550 Centraliser, For Cemented Use, REF 588.3800. Orthopedic hip implant component.
Brand
Corin Ltd Unit 1-57-8 Corinium Centre Cirencester United Kingdom
Lot Codes / Batch Numbers
Model #588.3800, Lot #494754, UDI 05055343871065
Products Sold
Model #588.3800, Lot #494754; UDI 05055343871065
Corin Ltd Unit 1-57-8 Corinium Centre Cirencester United Kingdom is recalling TaperFit Stem, Size 0, 38mm OFFSET, 12/14 Taper + 188.550 Centraliser, For Cemented Use, REF 588.380 due to Some of the devices did not pass fatigue testing.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Some of the devices did not pass fatigue testing.
Recommended Action
Per FDA guidance
The recalling firm issued the recall letter dated 7/8/2022 via email to the consignee on 7/12/2022. The recall letter described the potential issue and listed the affected product. The potential risk was reported and the actions to be carried out by the customer, which included return of the product from the field and completion of the acknowledgement form to be returned via email to confirm receipt of the letter.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
NJ
Page updated: Jan 10, 2026