FDA Medical Device Recalls (openFDA)
Biomet UK Ltd.: HipLOC Hip Fracture Fixation System-Hiploc System 135 Plate 38 mm Barrel 4 Hole Plate Item Number: 2110-135-004 Product Usage: The HipLOC Compression Hip Screw may be used primarily for fixation of bone fractures. Specific indications include open reduction and internal fixation of a wide variety of fractures of the proximal femur: intracapsular fractures, intertrochanteric fractures and subtrochanteric fractures
- Recall number
- Z-3263-2018
- Recalling firm
- Biomet UK Ltd.
- Product
- HipLOC Hip Fracture Fixation System-Hiploc System 135 Plate 38 mm Barrel 4 Hole Plate Item Number: 2110-135-004 Product Usage: The HipLOC Compression Hip Screw may be used primarily for fixation of bone fractures. Specific indications include open reduction and internal fixation of a wide variety of fractures of the proximal femur: intracapsular fractures, intertrochanteric fractures and subtrochanteric fractures
- Status
- Terminated
- Initiated
- 2018-08-09
- Posted
- not on file
- Terminated
- 2020-05-12
- Reason
- HipLOC System Plate Barrel due to an undersized bore on the HipLOC plate barrel, can result in the lag screw not fitting through the barrel
- Root cause
- Process design
- Action
- Zimmer Biomet issued US recall notices issued on August 9, 2018 via email and FedEx to Distributors and Hospitals advising of the problem and instruction to remove and return.Your Zimmer Biomet sales representative will remove the affected product from your facility. Complete Attachment 1 Certificate of Acknowledgement and send to CorporateQuality.PostMarket@zimmerbiomet.comnistructions.mailto:CorporateQQuality.PostMarket@zimmerbiomet.com.
- Quantity
- 44 units
- Distribution
- US Nationwide in the states of AZ, MO, NJ and NM
- Lot, serial or model codes
- Lot Number: 3222067 3355792 3609499 3609508 3619245 3623355 3623356 3700289 3700610 3829536 3843022 3847671 3847672 3879198 3879199 3879200 3879202 3889526 3897103 3897106 3897115 3902248 3918363 3918364
- 510(k) numbers
- ["K080685"]
- PMA numbers
- not on file
- Product code
- JDO
- Firm FEI
- 3002806535
- Firm city
- Bridgend
- Firm state
- not on file
- Firm country
- United Kingdom
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