FDA Medical Device Recalls (openFDA)
Zimmer Biomet, Inc.: Affixus Hip Fracture Nail, LH 130 DEG 9MM X 300MM
- Recall number
- Z-0442-2018
- Recalling firm
- Zimmer Biomet, Inc.
- Product
- Affixus Hip Fracture Nail, LH 130 DEG 9MM X 300MM
- Status
- Terminated
- Initiated
- 2017-08-07
- Posted
- not on file
- Terminated
- 2019-03-29
- Reason
- During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.
- Root cause
- Process change control
- Action
- Customers were notified via FedEx and/or email on approximately 08/07/2017. Instructions include ensure appropriate personnel are notified of the recall, locate and quarantine affected product in inventory, complete and return the Certification of Acknowledgement, return all affected product, and provide the names of hospitals or customers that would have received this product if further distributed.
- Quantity
- 638 units
- Distribution
- US nationwide distribution. Also Portugal and the Netherlands.
- Lot, serial or model codes
- Item No. 814609300; Lot No. (Exp. Date) UDI: 595480 (05/28/2027) UDI (01)00887868039676 (17)270528 (10)595480; 788380 (06/15/2027) UDI (01)00887868039676 (17)270615 (10)788380; 973000 (07/10/2027) UDI (01)00887868039676 (17)270710 (10)973000
- 510(k) numbers
- ["K100238"]
- PMA numbers
- not on file
- Product code
- HSB
- Firm FEI
- 1825034
- Firm city
- Warsaw
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28